Eye drop technology. Pharmacy technology for manufacturing drops for oral administration Drop technology
The methodological development can be used to conduct a practical lesson on the topic in the discipline MDK 02.01 “Technologies for the manufacture of dosage forms”, specialty 33.02.01. "Pharmacy". The purpose of creating a methodological development: to develop professional competencies in the production of water and alcohol drops according to recipes with a concentration of dry medicines of less than 3% or more (PC 2.1).
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GAPOU CO
"KALUGA BASIC MEDICAL COLLEGE"
Specialty: 02/33/01 “Pharmacy”
PM section. 02. Manufacturing of dosage forms
MDK 02.01. “Technology for making lek. forms"
Practical lesson No. 27-28
Topic 3.3. “Manufacture of drops containing one or more medicinal substances.
Prepared by: Chekmareva N.A.
2016
METHODOLOGICAL DEVELOPMENT FOR TEACHERS.
Section MDK 02.01.3. Production of liquid dosage forms
MANUFACTURING ALCOHOL DROPS"
GOALS:
1. Educational:
- To develop professional competencies in the production of water and alcohol drops according to recipes with a concentration of dry lek. funds less than 3%, 3% or more (PC 2.1).
- Teach students:
- check doses in aqueous, alcoholic, aqueous-alcoholic drops;
- select and justify the optimal method for producing droplets;
- filter liquids in small quantities;
- pack, prepare drops for release, evaluate the quality of manufactured drops;
- draw up primary accounting documents (PC 2.5).
- Continue to develop professional competencies in the skill of working with scales, weights, measuring instruments, and working with normative documents regulating the quality of drop production.
- Improve professional competence in organizing the workplace and compliance with sanitary and hygienic rules, safety regulations and fire safety (PC 2.4).
2. Educational:
- To instill in students a sense of professional responsibility and a conscious attitude towards the study of this topic.
- To develop the ability to work with additional specialized literature, to choose the main, essential things in the material studied (GC 4).
- To orient students towards the profession they are acquiring, to cultivate a feeling of love for the profession (OC 1).
3. Developmental:
- Continue to develop professional competence in dispensing medicines to the population, including with preferential prescriptions and according to the requirements of healthcare institutions (PC 1.2).
- To develop logical and analytical thinking in students.
- Develop the ability to highlight the main thing in the material being studied.
- Make decisions in standard and non-standard situations and take responsibility for them (OK 3).
- Work in a team and in a team, communicate effectively with colleagues, management, and consumers (OK 6).
TYPE OF CLASS: Laboratory and practical.
TRAINING METHOD: Independent practical work of students under the guidance of a teacher.
VENUE:Laboratories No. 208, 209.
DURATION OF CLASS: 180 min.
CLASS EQUIPMENT:
GF-X. VR-1.0, VR-5. Cylinders, eye droppers, napkins, cotton wool, a mixture of alcohol and ether, scissors, glue, threads, coupon rings, sealing wax, alcohol lamps, signature. Lek. Wedges: ephedrine hydrochloride, morphine hydrochloride, codeine phosphate, sodium bromide, adonizide, antipyrine, adrenaline hydrochloride, atropine sulfate solution 1%. Labels: “External”, “Internal”, “Keep in a dark place”, “Caution!”
GVA: “Dosing by weight. Scales. Weight", "Volume dosing methods", "State standardization of drug quality. funds", "Container. Packaging material. Storage, work, release of medicine. List A and B funds." “Solutions”, “Manufacture of solutions using concentrates”.
MDS:
Lat. language “Chem. nomenclature. Name of salts"
Pharmacognosy "Drugs acting on the central nervous system"
Pharmacology "Narcotic analgesics"
MDK 02.02. "KK LS, prod. amino alcohols" (adrenaline, hydrochloride, ephedrine hydrochloride), "KK LS, prod. isoquinoline" (morphine hydrochloride, codeine phosphate), "KK LS, prod. tropane" (atropine sulfate)
After studying the material yourself
students should KNOW:
- Checking doses in aqueous, alcoholic, aqueous-alcoholic drops.
FORMED COMPETENCIES:
1. GENERAL COMPETENCIES:
LEVEL OF COMPREHENSION: 3
CLASS STRUCTURE AND TIME REGIME:
- Organizational moment. Audience mobilization 2 min.
- Setting the goal of the lesson, its motivation 2 min.
- Incoming control 25 min.
a) analysis of recipes at the board 15 min.
b) objective testing 10 min.
- Guidelines for practical work 2 min.
- Doing practical work 113 min.
The teacher checks intermediate results and corrects students’ activities. Control over the development of practical skills, registration of a diary.
- Output control. Additional check of diaries 14 min.
- Summing up, homework assignment 2 min.
PROGRESS OF THE CLASS
1. Organizational moment. Audience mobilization.
The teacher greets the students, pays attention to the appearance of the students, accepts the report from the duty officer about the readiness of the office and students for class, and notes those who are absent.
2. Setting the goal of the lesson, its motivation.
The teacher notes that drops occupy about 15% of pharmacies’ formulations and have their own characteristics both in checking doses and in manufacturing techniques, unlike solutions, so pharmacists must know these characteristics in order to produce high-quality medicine. form, indicates the purpose of the lesson.
3. Incoming control.
I. Analysis of recipes at the board:
B: Morphine hydrochloride 0.03
Purified water 10 ml
About. 10 drops. 2 times a day, for pain.
B: Ethylmorphine hydrochloride 0.15
Belladonna tinctures
Motherwort tinctures 15 ml
About. 15 drops each. 3 times a day.
B: Validola 4.0
Nitroglycerin solution 1% -1 ml
Motherwort tinctures
Valerian tinctures 20 ml
About. 10 drops. apply sugar under the tongue for pain in the heart.
II. Knowledge control using objective testing method.
For this purpose, students are offered 2 test options with 10 tasks each. Tests of various types and levels of difficulty. The time is regulated by the teacher. To solvetest tasksDose tables and GF-X drop tables are required. Options included(Appendix No. 2).
4. Guidelines for practical work.
The teacher notes that in today's lesson it is necessary to make a lek. forms - drops, indicates which dishes to take, draws attention to the features of filtering liquids in small quantities, shows how to rinse the filter with water that is not included in the volume, manufacturing techniques based on the concentration of solids. means, checking for purity and the peculiarities of registration for the holiday, shows how to seal penicillin vials for the holiday, how to seal them.
5. Doing practical work.
Students receiveindividual recipes(Appendix No. 3). Organize a workplace and prepare a lek. forms, while completing the task, students use GF-X,manufacturing algorithms (Appendix No. 4).The teacher corrects the work of individual students, monitors the students’ development of professional competencies on this topic, and the students complete the lecture. medications for dispensing, fill out the back of prescriptions, PPC, fill out diaries, and as the work is completed, approach the teacher to take the medicine. drugs.
When taking medication. drugs, the teacher conducts organoleptic control, checks the PPC, diary and asks students the following questions, at the discretion of the teacher:
- What are drops?
- How are they classified?
- What does the drop making technique depend on?
- What is the technique for making drops with a concentration of dry lek. funds less than 3%?
- What is the technique for making drops with a concentration of dry lek. funds 3% or more?
- How to check doses in water drops?
- How to check doses in alcohol drops? If the alcohol strength is approximately the same, does it differ sharply?
- What is the technique for making alcohol drops?
- How are drops prepared for release?
1. GENERAL COMPETENCIES:
- OK 1. Understand the essence and social significance of your future profession, show sustained interest in it.
- OK 2. Organize your own activities, choose standard methods and ways of performing professional tasks, evaluate their effectiveness and quality.
- OK 3. Make decisions in standard and non-standard situations and take responsibility for them.
- OK 4. Search and use information necessary for the effective performance of professional tasks and professional personal development.
- OK 5. Use information and communication technologies in professional activities.
- OK 6. Work in a team and in a team, communicate effectively with colleagues, management, and consumers.
- OK 7. Take responsibility for the work of team members (subordinates) and for the results of completing tasks.
- OK 8. Independently determine the tasks of professional and personal development, engage in self-education, consciously plan to improve your qualifications.
- OK 9. To navigate the conditions of frequent changes in technology in professional activities.
2. PROFESSIONAL COMPETENCIES:
- PC 2.1. Prepare dosage forms according to prescriptions and requirements of healthcare institutions.
- PC 2.2. Produce in-pharmacy supplies and package medicines for subsequent sale.
- PC 2.4. Comply with sanitary, hygienic, safety and fire safety regulations.
- PC 2.5. Prepare primary accounting documents.
- PC 1.2. Dispense medicines to the population, including on preferential prescriptions and according to the requirements of healthcare institutions.
6. Output control.
It is recommended to do it in the formwritten surveyfor checking doses in water and alcohol drops using 10 options(DRF folder, 1 page, or KNF folder).Each student receives an individual assignment. The task consists of 5 recipes; when completing the task, students use the table of GF-X drops and dose tables. Time is regulated.
At the discretion of the teacher, the final control can be carried out in the formwritten survey onindividual options, where 2 recipes are given:
A) checking doses in water drops,
B) checking doses in alcohol drops(Appendix No. 5).
7. Summing up.
The teacher assigns a grade for the practice to each student, taking into account theoretical preparation for practical work, the grades are commented on. The teacher signs and draws students’ attention to individual professional competencies , the implementation of which was not at a high level. Recognizes students who have designed their lectures competently and aesthetically. drugs for release. The teacher asks the students “has the goal been achieved”?
Basic literature:
- Working with the teacher lit-roy.
Further reading:
Appendix No. 1. Methodological recommendations for students for self-preparation for practical training.
Appendix No. 2. Options for test tasks.
Appendix No. 3. Recipe to be performed during a practical lesson.
Appendix No. 4. Algorithm for producing water drops with the concentration of dry lek. funds up to 3%, 3% or more.
Appendix No. 5. Written survey options.
Appendix No. 1
SPECIALTY 060301
Professional module PM.02: Making medicines. forms and carrying out mandatory types of intra-pharmacy control.
Section PM 1. Production of dosage forms.
MDK 02.01. "Technology for the production of dosage forms."
Section MDK 02.01.3. Production of liquid dosage forms.
TOPIC 3.3.: “PRODUCTION OF DROPS CONTAINING ONE OR MORE LEC. SUBSTANCES
MANUFACTURING ALCOHOL DROPS"
GOALS:
- Test students' knowledge and skills on this topic.
- Build skills:
- Check doses in aqueous, alcoholic, aqueous-alcoholic drops.
- Select and justify the optimal method for producing drops.
- Practice the ability to prepare drops with a concentration of dry lek. funds less than 3%, 3% or more.
- Practice skills:
- Filter liquids in small quantities.
- Package, arrange drops for release, evaluate the quality of manufactured drops.
- Strengthen skills in working with scales, weights, and measuring instruments.
- Strengthen the ability to work with normative documents that regulate the quality of drop production.
- Improve your workplace organization skills.
CLASS TIME: 180 minutes.
VENUE:Laboratories No. 208, 209
KNOW:
- Checking doses in aqueous, alcoholic and aqueous-alcoholic drops.
- Rules for making drops in aqueous and non-aqueous solvents.
- Storage. Vacation
IN CLASS STUDENTS SHOULD:
- Answer questions from incoming inspection.
- Prepare drops in aqueous and non-aqueous solvents with a concentration of dry lek. funds up to 3%, 3% or more according to the proposed recipes, fill out a diary.
- Answer the final inspection questions.
SAMPLE RECIPE:
B: Morphine hydrochloride 0.1
Purified water 10 ml
D. Ob. 10 drops. 2 times a day.
B: Lily of the valley tinctures
Belladonna tinctures 10 ml
Sodium bromide 2.0
Purified water 20 ml
During practical work, students
acquire the following COMPETENCIES:
1. GENERAL COMPETENCIES:
- OK 1. Understand the essence and social significance of your future profession, show sustained interest in it.
- OK 2. Organize your own activities, choose standard methods and ways of performing professional tasks, evaluate their effectiveness and quality.
- OK 3. Make decisions in standard and non-standard situations and take responsibility for them.
- OK 4. Search and use information necessary for the effective performance of professional tasks and professional personal development.
- OK 5. Use information and communication technologies in professional activities.
- OK 6. Work in a team and in a team, communicate effectively with colleagues, management, and consumers.
- OK 7. Take responsibility for the work of team members (subordinates) and for the results of completing tasks.
- OK 8. Independently determine the tasks of professional and personal development, engage in self-education, consciously plan to improve your qualifications.
- OK 9. To navigate the conditions of frequent changes in technology in professional activities.
2. PROFESSIONAL COMPETENCIES:
- PC 2.1. Prepare dosage forms according to prescriptions and requirements of healthcare institutions.
- PC 2.2. Produce in-pharmacy supplies and package medicines for subsequent sale.
- PC 2.4. Comply with sanitary, hygienic, safety and fire safety regulations.
- PC 2.5. Prepare primary accounting documents.
- PC 1.2. Dispense medicines to the population, including on preferential prescriptions and according to the requirements of healthcare institutions.
INDEPENDENT WORK (homework):
Basic literature:
- Uch. V.I. Pogorelov "FT" R-on-D, Phoenix, 2002, pp. 183-184
- Working with the teacher lit-roy.
- Performing calculations and describing technol. making drops.
- Solving professional problems in the production, design and dispensing of liquid dosage forms.
Further reading:
- Uch. I.I. Krasnyuk, K.V. Mikhailova, L.I. Muravyov "FT", I. Ed. Geobar-Media group, 2011, pp. 221-223
Appendix No. 2
ANSWERS TO THE TEST SURVEY
OPTION 1 | OPTION 1 |
|||
B, G |
||||
1 – B |
||||
2 – A |
||||
3 – B |
||||
4 – B |
||||
5 – A |
||||
B, G | ||||
1 – B | ||||
2 – A | ||||
3 – B | ||||
4 – B | ||||
5 – A | ||||
EVALUATION CRITERIA:
15 – 14 answers – “5”
13 – 12 answers – “4”
11 – 10 answers – “3”
9 answers or less – “2”
Appendix No. 3
RECIPE FOR IMPLEMENTATION
IN PRACTICAL LESSON.
B: Morphine hydrochloride 0.1
Purified water 10 ml
D. Ob. 10 drops. 3 times a day.
B: Codeine phosphate 0.2
Sodium bromide 2.0
Adoniside 5 ml
Purified water 20 ml
D. Ob. 2 drops each 3 times a day.
B: Lily of the valley tinctures
Valerian tinctures 10 ml
Sodium bromide 1.0
Purified water 10 ml
D. Ob. 10 drops. 4 times a day.
B: Atropine sulfate solution 0.1% -10 ml
D. Ob. 8 drops each. For pain.
B: Ephedrine hydrochloride solution 3% -10 ml
D. Ob. 2 drops 3 times a day in the nose.
B: Norsulfazole solution 2% -10 ml
D. Ob. 2 drops per nose.
B: Boric acid 0.3
Alcohol 10 ml
D. Ob. Drops in the ear.
Recipes can be changed at the discretion of the teacher based on defects, taking into account the regional component.
Appendix No. 4
ALGORITHM FOR MANUFACTURING WATER DROPS.
Solid concentration lek. funds less than 3%. | Solid concentration lek. funds 3% and above. |
|
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Appendix No. 5
Option #1
Check doses:
B: Promedol solution 1% - 10 ml
D. Ob.: 5 drops. 2 r. per day for pain.
B: N-ki belladonna 3 ml
Motherwort n-ki 7 ml
N-ki hawthorn 10 ml
D. Ob.: 15 drops. 3 r. per day.
Option No. 2
Check doses:
B: Ethylmorphine solution g/chl 0.2 – 15 ml
D.O.: 10 drops. 2 r. per day.
B: Adoniside 5 ml
N-ki mint 3 ml
Motherwort n-ki 7 ml
N-ki valerian 10 ml
Option No. 3
Check doses:
B: Atropine sulfate 0.05
Purified water 10 ml
See D. Ob. 2 drops each 2 r. per day.
B: N-ki strophanthus 2 ml
N-ki valerian
N-ki wormwood 5 ml
Option No. 4
Check doses:
B: Atropine sulfate solution 0.3% - 20 ml
D. Ob. 4 drops each. 2 r. per day.
B: N-ki strophanthus 4 ml
N-ki valerian 16 ml
See D. Volume: 15 drops. 2 r. per day.
Option No. 5
Check doses:
B: Morphine hydrochloride 0.01
Purified water 10 ml
See D. Volume: 20 drops. 2 r. per day.
In: N-ki belladonna
N-ki valerian
Lily of the valley 10 ml
Option No. 6
Check doses:
B: Yoda 0.05
Potassium iodide 0.1
Purified water 50 ml
See D. Volume: 10 drops. 2 r. per day.
B: Adoniside 5 ml
N-ki valerian
Lily of the valley 10 ml
See D. Volume: 25 drops. 3 r. per day.
Option No. 7
Check doses:
B: Dionine solution 1% - 10 ml
B: N-ki belladonna 6 ml
Motherwort n-ki
N-ki valerian 5 ml
Lily of the valley 7 ml
See D. Volume: 30 drops. 2 r. per day.
Option No. 8
Check doses:
B: Apomorphine hydrochloride solution 0.2% - 10 ml
B: Menthol 0.2
N-ki belladonna
N-ki valerian
Lily of the valley 10 ml
See D. Volume: 15 drops. 3 r. per day.
Option No. 9
Check doses:
B: Atropine sulfate solution 0.02 – 15 ml
D.O.: 10 drops. 3 r. per day.
B: N-ki chilibukha 6 ml
N-ki wormwood
N-ki valerian 7 ml
See D. Volume: 10 drops. 3 r. per day.
Option No. 10
Check doses:
B: Scopolamine hydrobromide solution 0.1% - 10 ml
D. Ob.: drop by drop. 2 r. per day.
B: Nitroglycerin solution 1% - 5 ml
N-ki valerian
Lily of the valley 10 ml
See D. Volume: 5 drops. to the reception.
Option No. 11
r.d. 2 drops
s.d. 0.005
s.d. 6 drops
r.d. 0.0066
r.d. 3 drops
s.d. 0.0132
s.d. 9 drops
r.d. 0.005
r.d. 5 drops
s.d. 0.001
s.d. 10 drops
r.d. 0.0006
r.d. 3 drops
s.d. 0.0012
s.d. 6 drops
r.d. 0.001
r.d. 5 drops
s.d. 0.001
s.d. 15 drops
r.d. 0.0005
r.d. 5 drops
s.d. 0.001
s.d. 15 drops
r.d. 0.005
r.d. 8 drops
s.d. 0.015
s.d. 16 drops
r.d. 0.001
r.d. 5 drops
s.d. 0.003
s.d. 15 drops
r.d. 0.0006
r.d. 3 drops
s.d. 0.0018
s.d. 9 drops
r.d. 0.0005
r.d. 3 drops
s.d. 0.001
s.d. 9 drops
r.d. 0.00125
r.d. 2.5 drops (2.4)
s.d. 0.0025
s.d. 10 drops (9.6)
_INTERNATIONAL SCIENTIFIC JOURNAL “SYMBOL OF SCIENCE” No. 10-3/2016 ISSN 2410-700Х_
PHARMACEUTICAL SCIENCES
UDC 615.451.3
Vasileva Anastasia Vladimirovna
4th year student of the Faculty of Pharmacy of the Federal Budgetary Educational Institution of Higher Education KSMU MFK, Russian Federation, Kursk E-mail: [email protected] Boyko Inna Anatolyevna Federal Budgetary Educational Institution of Higher Education KSMU MFK, Russian Federation, Kursk E-mail: [email protected]
PRODUCTION TECHNOLOGY AND RANGE OF DROPS FOR EXTERNAL USE IN PHARMACY AND FACTORY PRODUCTION
Annotation
The article presents a study of the technological process of manufacturing drops for external use in pharmacies and factories, as well as a study of their range.
Keywords
Manufacturing technology, drops for external use, pharmacy and factory production, liquid dosage forms.
Introduction: liquid dosage forms occupy the main place (45-50%) in the formulation of modern pharmacies. Many different prescriptions for liquid medicines are prepared in factories. The focus of an individual formulation on a specific patient, affordability and high public confidence in pharmaceutically produced medicines indicate the importance of maintaining and improving pharmaceutical production. Currently, in medical practice, drugs in the form of drops are widely used to treat various diseases. Drops (Guttae) are a liquid dosage form intended for internal or external use, distinguished by a single group characteristic, drop dosage. Therefore, the study of the technology for producing drops for external use in pharmaceutical and factory production is very relevant.
Objectives of the study: to study the technological features of production and the range of drops for external use in pharmacy and factory production.
Research objectives: analyze bibliographic sources on the topic, study the technology for making drops for external use, consider general technological methods for making drops in a pharmacy, analyze the technology for making drops for the nose, ears and teeth, study the range of drops for external use.
Research results: having studied the technology for the production of pharmaceutical and factory-made drops, it was found that the drops are prepared by dissolving solid medicinal substances in appropriate solvents, or by mixing liquids. The tinctures are measured in order of increasing quantities. Tinctures with a strong odor are added last. When mixing alcoholic liquids with different alcohol contents, first mix liquids that are similar in strength to the alcohol they contain. Drops are dispensed in dropper bottles.
Based on the results of the studies, it was established that the range of medicines for the treatment of rhinitis is dominated by medicines produced in the form of liquid dosage forms - 62.8% and 93 medicines (MP), since the treatment of rhinitis is more convenient and effective with drops, which are filled with a liquid medicinal phase. Basic liquid
INTERNATIONAL SCIENTIFIC JOURNAL “SYMBOL OF SCIENCE” No. 10-3/2016 ISSN 2410-700Х
drops are medicines - 28.3% (42 LPs). During a comparative analysis of the Russian market and the local range of medicines for the treatment of rhinitis by type of dosage form, it was revealed that in the Russian Federation mainly tablet dosage forms are registered 29.1% (LP - 43), drops are in second place 28.3% (LP - 42), in the third - nasal sprays 24.3% (LP - 36). On the Kursk market, drops predominate - 32.5% (LP - 38), in second place are tablets 27.3% (LP - 32), in third place are nasal sprays 25.6% (LP - 30).
Conclusion: the preparation of drops consists of the following stages: dosing of solvent and medicinal substances; dissolution of medicinal substances; straining, packaging and packaging for release, assessing the quality of drops. Methods for making drops depend on the composition. They are prepared by dissolving solid medicinal substances in appropriate solvents or by mixing liquids. The range of drops for external use is extensive. In recent years, new drugs in the form of drops have appeared on the Russian pharmaceutical market. A huge number of drugs are used to treat rhinitis. The leading position among them is occupied by drops. List of used literature:
1. Grossman V.A. Pharmaceutical technology. - M.: GEOTAR-Media, 2014. - 512 p.
2. State Pharmacopoeia of the Russian Federation XII: Collection of basic standards used in pharmacopoeial analysis, production and circulation of medicines. - M.: Publishing house "Scientific Center for Expertise of Medicinal Products", 2008. - 704 p.
3. Unified rules for registration of medicines prepared in pharmacies (enterprises) of various forms of ownership. Guidelines, (approved by the Ministry of Health of the Russian Federation on July 24, 1997) [Electronic resource]. - Access mode: http://www.consultant.ru/State Pharmacopoeia of the Russian Federation XII: Collection
4. Register of medicines [Electronic resource]. - Access mode: http://www.rlsnet.ru/
©Vasileva A.V., Boyko I.A., 2016
UDC 615.454.1
Zheltukhina Alina Yurievna FSBEI HE KSMU Ministry of Health of the Russian Federation, 4th year student of the Faculty of Pharmacy
Email: [email protected] Scientific supervisor: Boyko Inna Anatolyevna Federal State Budgetary Educational Institution of Higher Education KSMU Ministry of Health of the Russian Federation Medical and Pharmaceutical College
Kursk, Russian Federation E-mail: [email protected]
PRODUCTION TECHNOLOGY AND RANGE OF PHARMACY AND FACTORY PRODUCED PASTES
Annotation
The article discusses the features of the manufacture of pharmaceutical and factory-produced pastes and their range.
Keywords
Pastes, pharmaceutical and factory production, assortment, technology.
Pastes are a soft dosage form intended for application to the skin, wounds or mucous membranes. The permeability of the skin to various medicinal substances increases sharply when the skin is hydrated with warm compresses and warm baths. Pastes consist of medicinal substances and a base. Home
1. OBJECTIVE: Learn to prepare drops - aqueous solutions of medicinal substances and evaluate their quality based on the theoretical provisions of the topic, the properties of medicinal substances and in accordance with the requirements of the ND.
2. Questions to prepare for the topic:
Characteristics of drops as a dosage form.
Classification of drops according to the method of administration and the nature of the solvent
Features of checking doses of toxic and potent substances in drops for internal use.
Technology of drops - aqueous solutions of medicinal substances.
Assessing the quality of drops and preparing them for release.
The main ways to improve the quality and technology of droplets.
3. Training material
Drops are a liquid dosage form intended for internal or external use, dosed in drops. The drops have all the advantages inherent in liquid dosage forms (high bioavailability compared to solid dosage forms, ease of use, ease of manufacture). But due to the higher concentration of medicinal substances compared to mixtures, chemical incompatibilities are relatively more common in drops. In extemporaneous pharmacy formulations, drops occupy about 15%.
Drops are qualified by application - for internal and external use (nasal drops, ear drops, dental drops, etc.). Dispersed systems can be: true solutions, colloidal solutions, emulsions, suspensions. By the nature of the solvent - aqueous and non-aqueous drops.
Preparation of drops consists of the following stages:
I. Preparatory stage:
Analysis of the composition of the recipe for compatibility.
Checking doses of toxic and potent substances (in drops for internal use) and dispensing standards for narcotic and intoxicating drugs.
Preparation of packaging and capping material.
Carrying out the necessary calculations.
II. Dissolution (dry medicinal substances in a calculated amount of purified water or the use of concentrated solutions of medicinal substances).
III. Filtration (using the “small volume filtration technique”).
IV. Packaging and design for release (in clear or orange glass bottles with tight-fitting stoppers and gaskets, label “External” or “Internal”, additional labels - according to the properties of the drops’ ingredients in accordance with the current ND).
V. Assessment of the quality of drops (checking documentation, correct packaging and design, organoleptic control, absence of mechanical inclusions, deviations in volume, selective chemical and survey control).
The peculiarity of the technology of drops - aqueous solutions of medicinal substances is due to the small volume of their prescription (usually 5-15 ml). In order to maintain volume and concentration, medicinal substances are dissolved in approximately half the amount of purified water. The resulting solution is filtered through a cotton swab, previously washed with purified water. The remaining amount of water is filtered through the same swab.
In industrial production, eye drops in tube-droppers are prepared in rooms of class II cleanliness under aseptic conditions. The room and equipment are subjected to wet cleaning, disinfection with a 3-5% phenol solution and sterilization with bactericidal lamps for 2 hours.
The dissolution is carried out in reactors with stirrers, then analyzed and alternately subjected to filtration (first to remove mechanical impurities, and then for sterilization). The resulting solution is placed in a sterilized apparatus for filling dropper tubes.
At the same time, the bodies and caps of the dropper tubes are manufactured.
The body with a capacity of 1.5±0.15 ml and a wall thickness of 0.5±0.1 mm is formed on an automatic machine in several stages by blowing and stamping from high-pressure polyethylene granules of grade 15803-020 or 16803-070. The piercing pin caps are pressure-molded from molten pellets of 20906-040 or 20506-007 low-density polyethylene. After manufacturing, they are washed with distilled water, dried and subjected to gas sterilization at 40-50 with a mixture of ethylene oxide and 10% carbon dioxide for 2 hours. Ethylene oxide is removed from the products by keeping them for 12 hours in a sterile room. Next, under aseptic conditions in a unit with excess pressure of sterile air, the caps are screwed onto the body, filled with a solution of the medicinal substance using dosing pumps, and sealed by heat sealing. On a printing machine, an inscription is applied to the body on both sides with the name of the drug, indicating its concentration and volume. Filled dropper tubes are checked visually for the absence of mechanical inclusions on a black and white background when illuminated with a 60 W electric lamp, 5% of each batch is subjected to full analysis. The dropper tubes are packaged in single cases, cardboard boxes or polyvinyl chloride film.
In addition to this packaging, according to GOST 17768--80, glass bottles with a pipette stopper made of unstabilized low-density polyethylene are recommended for eye drops. Before filling, the solution is sterilized by filtration, and the pipette tubes are gas sterilized with ethylene oxide with 10% carbon dioxide.
Monitoring ophthalmic solutions for mechanical inclusions
Eye drops must be completely transparent and not contain any suspended particles that can cause mechanical damage to the membranes of the eye. Eye drops should be filtered through the best grades of filter paper, and a small ball of long-fiber cotton wool should be placed under the filter. It is important that after filtration the concentration of the solution and its total mass do not decrease more than allowed by established standards. Everything that has been said about filtering small quantities of solutions fully and primarily applies to eye drops. According to the recipes often found in the recipe, it is advisable to resort to the help of in-pharmacy preparations - concentrates prepared for a set period of time, which frees you from filtering small quantities of liquids.
Nomenclature of eye drops produced in tube droppers and bottles.
The range of dosage forms for the eyes currently produced at the factory in dropper tubes is still small and, of course, needs further expansion. However, this problem is not simple and easily solvable, since the development of technical standards for each new name of a medicinal substance is associated with the solution of a number of issues. First of all, from the huge number of prescriptions for eye medications, one should select and analyze those that are constantly found in eye practice throughout the country or, at least, in large populated areas. Next, it is necessary to determine the most commonly used concentrations of the drug substance, and these values \u200b\u200bmust be sufficiently stable or maintained at a constant level by adding stabilizers.
Finally, appropriate methods for analyzing both the drug itself and other components of the drug must be available or developed. Only after this can one begin to study the interaction of polymer packaging materials with a solution of a medicinal substance during the production process, sterilization and storage conditions. It should also be taken into account that at the final stage of these studies, which sometimes last for a long time, negative results may be obtained. In this case, you have to start all over again and continue searching for other optimal options.
Methods for purifying solutions of medicinal substances, along with ensuring sterility, an equally important problem in the industrial production of ophthalmic medicinal products in new forms of packaging is the absence of mechanical inclusions in solutions. To solve it, it is planned to carry out appropriate measures in two directions: cleaning solutions of medicinal substances and maintaining industrial cleanliness in production premises.
Based on the results of the work carried out to study the influence of the process of freezing solutions of eye drops on their physicochemical properties, notes were included in the “Storage” section in the relevant pharmacopoeial articles: “Freezing during transportation and storage is not a contraindication to its use.”
At the same time, additional experiments were carried out on storing eye drops in polymer packaging in a frozen state in order to study the possibility of extending their shelf life. For the experiments, preparations of sodium sulfacyl (20%) and zinc sulfate (0.25%) with boric acid (2%) produced by industry on a wide scale were selected. Eye drops were stored at a temperature of 10±2°C, and their qualitative and quantitative indicators were checked at certain intervals for compliance with the requirements of pharmacopoeial monographs.
Currently, work in this direction continues. Increasing the shelf life of eye drops and improving the production technology of plastic containers
Figure 3. Pharmaceutical equipment
TARGET: Be able to prepare eye drops, lotions, register for vacation and evaluate their quality.
MATERIAL EQUIPMENT
1.Tables. 2.Penicillin bottles with a capacity of 10 to 20 ml. 3.Cylinders: 5 ml, 10 ml, glass funnels, sticks, stands. 4. Mortars with pestles of various sizes, evaporating porcelain cups, glass ointment jars with a capacity of 20, 50 g with lids. 5. Electric baths. 6. VSM scales of different standard sizes with weights, technical pharmacy scales up to 1 kg. 7. Ashless filters, glass filters No. 2 and No. 3. 8. Heater for heating and melting ointment bases. 6. Sterile substances of medicinal substances, excipients and bases for ointments. 9. Metal or plastic spatulas, celluloid plates (scrapers). 10. Pharmaceutical substances, concentrated solutions. 11. Cotton wool, filter paper. 8.Scissors and paper capsules. 9. Alcohol-ether mixture (1:1). 10.Labels: “External”, “Eye drops”, “Store in a place protected from light”, “Store in a cool place at a temperature of 8 0 C-15 0 C”, auxiliary material for preparing dosage forms for dispensing. 11. Device for crimping caps on POK-3 bottles. 12.UK-2 device for monitoring injection solutions for mechanical inclusions. 13. Steam and air sterilizers, infusion-sterilization devices. 14.Starch paste. 15. Samples of eye drops and lotions prepared and prepared for release.
TEST QUESTIONS
1. Dosage forms used in ophthalmic practice. Conditions necessary for the manufacture of dosage forms for the eyes. Requirements for eye drops.
2. Features of eye drop technology. Containers and packaging for packaging.
3. Filter materials used for filtering eye drop solutions.
4. Substances used for isotonic eye drops. Buffering solutions used for eye drops.
5. Conditions for the preparation and storage of concentrated solutions used for the preparation of eye drops. Equipment used in the manufacture of eye drops.
6. Dispensing of eye drops and their shelf life. Assessment of the quality of eye drops and lotions. Eye films.
TRAINING MATERIAL
Ophthalmic dosage forms are a group of dosage forms used by instillation onto the mucous membrane of the eye.
A feature of the mucous membrane of the eye is the greatest sensitivity in comparison with all mucous membranes of the body. It reacts sharply to external stimuli: mechanical inclusions, discrepancy between the osmotic pressure and pH value of drugs administered into the eye and the osmotic pressure and pH value of the tear fluid.
Tear fluid is a protective barrier for microorganisms. In a healthy eye, it is bactericidal, which is explained by the presence of lysozyme (muromidase), which is capable of lysing microorganisms that enter the conjunctiva. But in pathological conditions of the eye, the content of lysozyme in the tear fluid is significantly reduced.
Another protective barrier for microorganisms is the epithelium of the cornea. If this barrier is damaged, some microorganisms multiply rapidly, causing severe illness, including loss of vision.
Thus, for the manufacture of ophthalmic dosage forms, it is necessary to take into account the anatomical, physiological and biochemical characteristics of the organ of vision, as well as factors influencing the therapeutic activity of this group of dosage forms.
The pharmacy worker is obliged to draw the patient’s attention to the correct use of eye drops (Fig. 81).
Rice. 81. Proper instillation of solution into the eye
Consumer Information
1. Wash your hands.
2. If the bottle of drops is transparent, check the solution before use (if the color has changed or a sediment has appeared).
3. Tilt your head back and look at the ceiling.
4. Pull down the lower eyelid with your finger.
5. Release one drop of solution from a pipette or bottle into the cavity formed behind the lower eyelid. You can use a mirror or call someone for help.
It is important that the dropper or vial tip be kept as close to the eye as possible, but not touching it.
6. If possible, keep the eyelid open without blinking for 30 seconds.
7. To increase the effectiveness of the installation, press your finger on the outer corner of the eye to prevent blinking for 1 minute.
8. Close the bottle tightly.
Ophthalmic dosage forms are divided into 4 types:
ü solutions;
ü films.
In ophthalmic practice, instillation of solutions, placement of ointments, films, tablets, lamellas into the conjunctival sac are widely used; shading and powdering the surface of the cornea or conjunctiva, administering drugs intracorneal, retrobulbar, into Tenon's space and using electrophoresis.
Eye drops- a liquid dosage form intended for instillation into the eye. They are aqueous or oily solutions of medicinal substances, most often antiseptics, anesthetics and substances that reduce intraocular pressure.
Main disadvantage eye drops is the low bioavailability of drugs as a result of a complex mechanism of absorption, an ineffective method of administration (drops) and washout of the drug with tear fluid. It has been established that only 1/10 of the dose of the drug penetrates the eye. Therefore, the pharmacy worker is obliged to inform the patient how to properly use eye drops.
Eye drops should:
ü be prepared under aseptic conditions and be sterile;
ü withstand tests for mechanical inclusions;
ü should not have a toxic or irritating effect;
ü be comfortable to use (isotonic, isohydric with tear fluid);
ü be stable in conditions of frequently opened packaging.
There is no requirement for eye drops to be non-pyrogenic. It has been proven that with this method of application, pyrogenic substances do not enter the blood. In this regard, eye drops are prepared on purified water, and not on water for injection.
To stabilize the physicochemical, microbiological and rheological properties, auxiliary substances are introduced into the drops:
ü preservatives,
ü antioxidants,
ü thickeners,
ü stabilizers,
ü prolongators.
The concentration and volume (or mass) of isotonic and stabilizing substances added to eye drops must be indicated not only in passports, but also on prescriptions.
The production and quality control of sterile solutions in pharmacies is carried out in accordance with the requirements of the State Pharmacopoeia. The technology for making eye drops is no different from preparing drops for internal use, but has some features. Particular attention in the manufacture of ophthalmic dosage forms should be paid to compliance with the principles of sterility and isotonicity, which primarily ensure the safety of the effects of drugs by gradual dissolution of the film in the tear fluid, reduce the number of drug administrations (up to 1-2 times a day), increase their therapeutic concentration in the tissues of the eye, reduce the course of treatment by 2-3 times, and also carry out treatment in conditions where other methods of using drugs are difficult or impossible.
According to the State Fund of the Republic of Belarus, sterility - a necessary requirement for all ophthalmic dosage forms. Sterility - absence of microbial contamination of the dosage form. Contaminated drugs can cause eye infections, which can lead to vision loss.
Ophthalmic dosage forms are prepared under aseptic conditions similar to injection solutions. Compliance with strict aseptic rules is the same for dosage forms that are not subjected to or subject to further sterilization. Of course, the role of asepsis increases for those forms that are not subsequently subject to heat treatment (ophthalmic dosage forms containing heat-labile substances; emulsions; suspensions). In this case, compliance with the rules of asepsis is the only way to ensure the proper quality of ophthalmic products.
However, aseptic manufacturing conditions do not guarantee complete protection of the dosage form, including eye drops, from microbial contamination. In this regard, eye forms must be sterilized.
To prepare eye drops, sterile solvents are used: purified water, isotonic buffer solutions, oils, etc. Sterile solutions are packaged in sterile bottles.
Eye drops must be sterile.
The method of sterilizing eye drops depends on the stability of medicinal substances in solutions to temperature effects. According to the sterilization mode, eye drops can be divided into 3 groups:
1. Drops without adding stabilizers, sterilized for 8-12 minutes with steam under a pressure of 1.1 atm and 120 0 C or 30 minutes with flowing steam.
This method is used to sterilize solutions of: atropine sulfate, boric acid, dicaine, potassium iodide, calcium chloride, sodium chloride, nicotinic acid, pilocarpine hydrochloride, proserine, riboflavin, sulfopyridazine sodium, furatsilin, zinc sulfate, ephedrine hydrochloride, as well as eye drops containing riboflavin in combination with ascorbic acid and glucose, etc.
2. Drops with added stabilizers, which can be sterilized with steam under pressure or with flowing steam.
Checking the sterility of eye drops produced in pharmacies is the responsibility of the bacteriological laboratories of the territorial centers of hygiene, epidemiology and public health (TsGE and OZ).
Eye drops must remain sterile when the packaging is frequently opened.
Eye drops, regardless of sterilization conditions, can become contaminated with microorganisms during use (repeated use from one bottle). To prevent microbial contamination of eye drops during use, it is proposed to include the following: preservatives :
ü chlorobutanol hydrate (0.5%),
ü benzyl alcohol (0.9%),
ü esters of parahydroxybenzoic acid (nipagin and nipazole, 0.2%),
ü quaternary ammonium salts (benzalkonium chloride, 0.01%),
ü sorbic acid (0.05-0.2%), etc. (Table 46).
Table 46. Maximum concentration of preservatives in ophthalmic solutions
Preservatives do not have a sterilizing effect. The introduction of preservatives does not guarantee sterility, but maintains a stable level of microbial contamination in conditions of frequently opened packaging.
Regardless of the presence of preservatives, patients should be advised to seal the vial after use and boil the pipettes.
For ophthalmic solutions, dropper bottles (Fig. 82) and glass tube bottles are used, which are closed with rubber stoppers and rolled up with aluminum caps. The bottles are made from a glass tube (drota) brand NS; bottles are designed for packaging and storing medicines. The bottles comply with TU 9461-010-00480514-99.
Rice. 82. Dropper bottles made of polyethylene and glass.
AB rubber stoppers are intended for sealing dart bottles with medications. AB rubber plugs comply with TU 38.006108-95.
Aluminum caps K-1 (TU 9467-004-39798422-99). They are made of aluminum foil 0.2 mm thick (Fig. 83).
During the production process, it is necessary to carry out degreasing after stamping and chemical treatment to remove machine oil.
To seal bottles, stoppers of special types of rubber are used: IR-21 (silicone), IR-119, IR-119A (butyl rubber). New rubber plugs are treated to remove sulfur, zinc and other substances from their surface in accordance with the instructions. Used corks are washed with purified water and boiled in it 2 times for 20 minutes, sterilized at 121+2 °C for 45 minutes.
Rice. 83. Bottles made of glass tube (drota) brand NS; AB rubber plugs; aluminum caps K-1.
Bottles with solutions, sealed with rubber stoppers, are checked for the absence of mechanical inclusions. If mechanical inclusions are detected during the initial control of the solution, it is filtered.
After production, the solutions are subjected to chemical analysis, which consists in determining the authenticity (qualitative analysis) and quantitative content of medicinal substances included in the dosage form (quantitative analysis). If the result is positive, they are rolled in with metal caps.
Rolled bottles with solutions are marked with an aluminum cap, indicating the name and batch number.
Labeled vials are placed in an autoclave and sterilized in accordance with the instructions of the State Fund, taking into account the volume of solution in the vessel. After sterilization, the solutions are analyzed for the content of mechanical inclusions. Rejected bottles cannot be recycled.
Rejected vials are sent for full analysis in accordance with the requirements of the State Fund of the Republic of Belarus or the Federal Fund.
A sample is taken for sterility analysis. If the result is positive, they are marked and packaged in corrugated boxes.
Thus, technology for producing ophthalmic solutions(Fig. 84) is practically no different from the technology for producing injection solutions, except that due to the small volumes of eye drops, it is often necessary to weigh a sample of substances of lists “A” and “B” weighing less than 0.05 g, which is prohibited by the requirements of the pharmacopoeia. To overcome this obstacle, it is recommended to use concentrated solutions.
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Rice. 84. Typical scheme for obtaining ophthalmic solutions.
No mechanical impurities in drops is achieved by filtration. Use paper filters, glass No. 3 and No. 4. Currently, membrane filtration is widely used (membrane filters with a maximum pore diameter of 0.3 μm), which make it possible not only to free solutions from mechanical impurities, but also to simultaneously carry out filter sterilization (especially for heat-labile substances). Filtration is carried out in a bottle previously rinsed with filtered water.
Eye drops are prepared in small volumes of 5-10 ml. To ensure the safety of the active ingredients and the volume of the dosage form, the so-called “double cylinder” method is used. There are three cases:
1. The substance is easily soluble in water, less than 3% is prescribed. Measure out the solvent and divide it into two parts. The substance is dissolved in one, the resulting solution is filtered through a filter pre-washed with clean water into a bottle for dispensing. Then the remaining amount of solvent is passed through the same filter.
2. The substance is easily soluble in water, but more than 3% is prescribed. The difference is that the solution is filtered not into a dispensing bottle, but into a graduated cylinder. First, the solution is passed through the filter, then a pure solvent, and the last portions are passed drop by drop.
3. The substance is soluble in the entire prescribed volume of water. In this case, the solution is filtered through a dry filter into a graduated cylinder, and then some pure solvent is passed through the filter, which displaces the solution from the filter.
During the manufacturing process, solutions are subjected to primary and secondary control for the absence of mechanical inclusions.
Primary control is carried out after filtering and packaging the solution. At the same time, each bottle of solution is examined. If mechanical inclusions are detected, the solution is filtered again, inspected again, sealed, labeled and sterilized.
100% of bottles with solutions that have passed the sterilization stage before their design and packaging are also subject to secondary control.
The quality of the in-pharmacy stock is checked by examining 30 bottles for the absence of mechanical impurities. The control time accordingly is: from 2 to 5 bottles with a capacity of 5-50 ml - 8-10 s.
Comfort the use of eye drops is one of the biopharmaceutical factors that determines the absence of unpleasant sensations during instillation of the drug. It is achieved by isotonizing eye drops or adjusting the pH to the pH level of the tear fluid.
Isotonation is carried out by introducing the calculated amount of sodium chloride into the solution.
It has been shown that eye drops do not cause discomfort if their osmotic pressure corresponds to the osmotic pressure of sodium chloride in a concentration of 0.7 to 1.1% solution. The use of solutions with an osmotic pressure value beyond the specified limits leads to burning and irritation of the mucous membrane of the eye (Table 47).
Sometimes doctors specifically prescribe hypertensive eye drops. The effect of drugs in this case, especially antimicrobial ones, occurs much faster.
Table 47. Compositions of iso-, hyper- and hypotonic eye drops
| Copybook | Equivalent concentration of sodium chloride,% | Amount of sodium chloride required for isotonication, g | |
| Isotonic solutions | |||
| 1.Riboflavinum 0.002 Solutio Kalii lodidi 3% 10 ml 2. Solutio Zinci sulfatis 0.25% 10 ml Acidum boricum 0.2 | 1.5 (0.35 × 0.3 × 10) 1.6 (0.53 × 0.2 × 10) | - | |
| Hypertonic solutions | |||
| 3.Solutio Sulfacyli-natrii 30% 10 ml Ribonavinum 0.002 4. Kalium iodidum 0.3 Solutio acidi borici 2% 10 ml | 6.9 (0.23×3×10) 2.1 (0.35×0.3×10 + 0.53×0.2×10) | - | |
| Hypotonic solutions | |||
| 5. Solutio Pilocarpini hydrochloridi 1% 10ml Riboflavinum 0.002 6. Acidum ascorbinicum 0.02 Solutio Glucosi 2% 10 ml | 0.22 (0.22×0.1×10) 0.36 (0.26×0.2×10) | 0,068 (0,09-0,022) 0,054 (0,09-0,036) | |
Very often, eye drops turn out to be hypotonic; their osmotic pressure must be “brought up” to the osmotic pressure of the tear fluid.
