Pilocarpine hydrochloride, eye drops. Section: Ophthalmic dosage forms

It is used when the volume of the solution does not exceed 10 ml and a sample of the drug can be weighed on a manual scale in accordance with the weighing rules.

In this case, concentration and volume accuracy is achieved.

In half the prescribed volume of water in a penicillin bottle, dissolve medicinal substances and an isotonic agent and filter the solution through moistened SBF with PTDV into a measuring cylinder. Through the same filter, water is added to the specified volume; pour into a penicillin bottle for release.

Exercise.

Prepare a solution of pilocarpine hydrochloride 1% - 10 ml eye drops prescription for a chronically ill patient.

Answer algorithm.

Rp: Sol. Pilocarpini hydrochloridi 1% - 10 ml 0.1 pilocarpine

D.S. Eye drops. 0.068 (0.07) NaCl

up to 10 ml of water for in.

Characteristic:

Peculiarities.

1. Pilocarpine hydrochloride is a Schedule A drug, but is not subject to PCU. The prescription form, form 107-U, is additionally issued with the inscription “For a chronic patient. Dispense 2 bottles every 10 days for 1 year.” The additional inscription is sealed and signed by the doctor and the seal “For prescriptions.” The prescription is valid for 1 year.

2. We check the concentration according to order No. 214 (1%, 2%, 4%, 6%) and underline it with a red pencil (order No. 330).

6. Eye drops must be isotonic

= 0,09 –(0,1*0,22)=0,068=0,07

The amount of isotonic agent is indicated in the PPK and on the reverse side

The calculated amount of pilocarpine can be weighed out on a hand scale; the volume of the solution is 10 ml, so we use the “two cylinders” method for preparation.

8. List A drug, therefore:

· We receive it from the pharmacist-technologist by filling out the back side of the prescription

· In the passport – “A”

PHC – mandatory 1 time before sterilization

· Additional "Handle with Care" label

· It is not sealed, as the closure is for running-in.

10. Eye drops must be sterile. 120 0 – 8 min. An additional “Sterile” label is not needed.

11. Shelf life 30 days.

12. Until the patient leaves, it is kept in a safe.

13. Used in the treatment of glaucoma.

Preparation.

Pour about 5 ml of water into a penicillin bottle, get 0.1 pilocarpine hydrochloride dissolved from the pharmacist-technologist. Weigh and dissolve 0.07 sodium chloride. Prepare the filter. We filter the solution into a cylinder and, through the same filter, bring the volume to 10 ml, pour 1 ml for analysis. We fill out the PPK.

Pour the solution into a penicillin bottle for dispensing, check for purity, seal it for testing, and pre-label it:

Sol. Pilocarp. 1%

1.09.09 Signature.

Sterilize in an autoclave at 120 0 – 8 min. We carry out a marriage. We are preparing for vacation.

Exercise.

Prepare a solution of sodium sulfacyl 10% 10 ml eye drops according to the prescription

Answer algorithm.

Rp: Sol. Sulfacyli- Natrii 10% - 10 ml 1.0 sodium sulfacyl

D.S. Eye drops. 0.015 (0.02) Sodium thiosulfate

0.1 M HCl -0.35 ml

up to 10 ml of water for in.

Characteristic: This dosage form is a complex liquid, aqueous true solution for eye instillation.

Peculiarities.

2. We check the concentration according to order No. 214 (10%,20%, 30%).

3. We write out a label with the composition “Unified rules for design...”.

5. Eye drops must be isotonic. In this case, the concentration is high and the drops are hypertonic. When dispensing drops, the patient must be warned about discomfort.

6. Eye drops must be stable. Sodium sulfacyl is an easily oxidized substance. Stabilization in accordance with Order No. 214.

Composition of stabilizer per 10 ml, regardless of concentration

0.015 Sodium thiosulfate

0.1 M HCl -0.35 ml

HCl + Na 2 S 2 O 3 NaCl + H 2 O + SO 2 + S

SO 2 - acts as an antioxidant.

The amount of stabilizer is indicated in the PPK and on the back of the recipe.

7. The concentration of the solution must be accurate.

The calculated amount of the drug can be weighed out on a hand scale; the volume of the solution is 10 ml; therefore, for preparation we use the “two cylinders” method.

8. Add 0.1 M HCl with an analytical pipette, as an exception in drops.

9. Dissolution order: sodium thiosulfate, sodium sulfacyl, 0.1 M HCl.

10. Eye drops must be clean. Filter through moistened SSF with PTDV. We check for cleanliness 2 times.

11. PHC – selectively, first of all, 1 time before sterilization.

12. Eye drops must be sterile. Sterilize at 120 0 – 8 min. An additional “Sterile” label is not needed.

13. Shelf life 30 days.

14. Used in the treatment of conjunctivitis, prevention of gonoblenorrhea in newborns.

Exercise.

Prepare eye drops with glycerin according to the recipe.

Answer algorithm.

Rp: Sol. Glycerini 40% - 10 ml 4.44 glycerin 90%

D.S. Eye drops. up to 10 ml of water for in.

Characteristic: This dosage form is a complex liquid, aqueous true solution for eye instillation.

Peculiarities.

1. Check that the prescription is written correctly. Prescription form form 107-U.

2. We check the concentration in accordance with the therapeutic effect.

3. We write out a label with the composition “Unified rules for design...”

4. We prepare under aseptic conditions according to orders No. 308 and 309.

5. We carry out calculations on the reverse side of the PPK.

6. Glycerin is calculated in terms of anhydrous

7. Eye drops must be isotonic. In this case, the concentration is high and the drops are hypertonic. When dispensing drops, the patient must be warned about discomfort.

In this case, we prepare the mass-volume method, since glycerin is a viscous liquid.

9. Eye drops must be clean. Filter through moistened SSF with PTDV. We check for cleanliness 2 times.

12. Shelf life 30 days.

13. Used as a dehydrating agent.

Exercise.

Prepare eye drops with quinine hydrochloride according to the recipe.

Answer algorithm.

Rp: Sol. Chinini hydrochloridi 1% - 10 ml 0.1 quinine hydrochloride

D.S. Eye drops. 0.08 NaCl

Up to 10 ml of water for in.

Characteristic: This dosage form is a complex liquid, aqueous true solution for eye instillation.

Peculiarities.

1. Check that the prescription is written correctly. Prescription form form 107-U. Schedule B drug.

2. We check the concentration according to order No. 214 (1%).

3. We write out a label with the composition “Unified rules for design...”.

4. We prepare under aseptic conditions according to orders No. 308 and 309.

5. Quinine hydrochloride MP 1:30, dissolve in hot water.

6. Eye drops must be isotonic.

0.09 –(weighed portion of the drug * isotonic equivalent)

= 0,09 –(0,1*0,14)=0,076=0,08

The amount of isotonic agent is indicated in the PPC and on the back of the recipe.

7. Eye drops must be stable. Quinine hydrochloride is a salt of an alkaloid; in the presence of the ion of the same name, the base may precipitate. Therefore, dissolve quinine hydrochloride in 7-8 ml hot water. Add sodium chloride after complete cooling.

8. The concentration of the solution must be accurate.

The calculated amount of the drug can be weighed out on a hand scale, the volume of the solution is 10 ml, so we use the “two cylinders” method for preparation.

9. Eye drops must be clean. Filter through moistened SSF with PTDV. We check for cleanliness 2 times.

10. PHC – selectively, first of all, 1 time before sterilization.

11. Eye drops must be sterile. Sterilize at 120 0 – 8 min. An additional “Sterile” label is not needed.

12. Shelf life 120 days.

13. Used in the treatment of diseases caused by protozoan microorganisms.

Pilocarpine hydrochloride: instructions for use and reviews

Latin name: Pilocarpine hydrochloride

ATX code: S01EB01

Active substance: pilocarpine

Manufacturer: RUP Belmedpreparaty (Republic of Belarus)

Updating the description and photo: 26.11.2018

Instructions for medical use medicine

PILOCARPINA HYDROCHLORIDE

Tradename

Pilocarpine hydrochloride

International nonproprietary name

Dosage form

Eye drops 1% 5 ml

1 ml of solution contains

active substance – pilocarpine hydrochloride - 10 mg,

excipients: boric acid, water for injection – up to 1 ml.

Description

Transparent colorless liquid

Pharmacotherapeutic group

A drug for the treatment of eye diseases. Parasympathomimetics.

PBX code S01EB01

Pharmacological properties

Pharmacokinetics

Penetrates well into the cornea. It is practically not absorbed in the conjunctival sac and does not have a resorptive effect.

The time required to achieve maximum concentration in the intraocular fluid is 30 minutes. Retains in the tissues of the eye, which prolongs its half-life, which is 1.5 - 2.5 hours.

It is excreted unchanged with the intraocular fluid.

Pharmacodynamics

M-cholinergic stimulating agent, has a miotic and antiglaucoma effect. Increases the secretion of the digestive, bronchial and urinary glands, the tone of the smooth muscles of the bronchi, intestines, gall and bladder, and uterus.

Causes a contraction of the circular (miosis) and ciliary muscles (spasm of accommodation), increases the angle of the anterior chamber of the eye (the root of the iris is retracted), increases the permeability of the trabecular zone (the trabecula is tightened, and the blocked areas of Schlemm’s canal open), improves the outflow of aqueous humor from the eye and ultimately reduces intraocular pressure.

In primary open-angle glaucoma, instillation of a 1% solution causes a decrease in intraocular pressure by 25-26%. The onset of the effect is after 30-40 minutes, reaches a maximum after 1.5-2 hours and lasts for 4-14 hours.

Indications for use

Acute attack of angle-closure glaucoma

Secondary glaucoma

Primary open-angle glaucoma (as monotherapy and in combination with beta-blockers or other drugs that reduce intraocular pressure

The need for pupil constriction after instillation of mydriatics (except for persons with myopia high degree).

Directions for use and doses

Instill 1-2 drops into the conjunctival sac of the affected eye 1-3 times a day. The number of instillations may vary depending on the indications and individual sensitivity of the patient.

To treat an acute attack of angle-closure glaucoma, pilocarpine solution is instilled every 15 minutes during the first hour, every 30 minutes for 2-3 hours, every 60 minutes for 4-6 hours and then 3-6 times a day until the attack stops.

The doctor prescribes the course of treatment individually.

Side effects

Headache (temporal or periorbital areas)

Pain in the eye area

Decreased vision, especially at night, due to the development of persistent miosis and spasm of accommodation

Tearing

Allergic reactions

Rhinorrhea

Superficial keratitis

With long-term use, the development of follicular conjunctivitis and contact dermatitis is possible.

Contraindications

Individual sensitivity to the components of the drug

Iridocyclitis

Keratitis

Condition after ophthalmological operations and other eye diseases in which constriction of the pupil is undesirable.

Drug interactions

Antagonists of pilocarpine are atropine and other M-anticholinergic drugs. When used simultaneously with hormone stimulants, the effect is antagonistic (on pupil diameter).

Timolol and phenylephrine enhance the decrease in intraocular pressure (reduce the production of intraocular fluid).

It can be used in combination with sympathomimetics, beta-blockers, and carbonic anhydrase inhibitors.

M-cholinergic stimulating activity is reduced by tricyclic antidepressants, phenothiazine derivatives, chlorprothixenol, clozapine; enhanced by anticholinesterases medicines.

It is possible to develop bradycardia and a decrease in blood pressure during general anesthesia with the use of fluorotane (in patients using pilocarpine in eye drops).

special instructions

Treatment must be carried out with regular monitoring of intraocular pressure.

Carefully

In patients with a history of retinal detachment and in young patients with high myopia.

Pregnancy and lactation

Use during pregnancy is only possible if the expected benefit to the mother outweighs the potential risk to the fetus. If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be resolved.

Features of the effect of the drug on the ability to drive vehicle or potentially dangerous mechanisms

In the presence of initial cataracts, the miotic effect may cause a transient deterioration of vision, therefore, during the treatment period, caution must be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

INSTRUCTIONS
on medical use of a medicinal product

Registration number:

Tradename:

Pilocarpine

INN or group name:

Chemical name: (3S-cis)-3-Ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl]-2(3H)-furanone (as hydrochloride)

Dosage form:

Composition per 1 ml:

Active substance:
Pilocarpine hydrochloride – 10 mg
Excipients:
boric acid – 12.5 mg
sodium hydroxide 1 M to pH 3.5-5.0
water for injection up to 1 ml

Description: Transparent colorless liquid

Pharmacotherapeutic group:

ATX code:

Pharmacological properties

Indications for use

Contraindications

Carefully
In young patients with high myopia.
If you have one of the listed diseases, be sure to consult your doctor before taking the drug.

Use during pregnancy and breastfeeding

Directions for use and doses

Place 1-2 drops into the conjunctival sac. The number of installations may vary depending on the indications and individual sensitivity of the patient.
Acute attack of closed glaucoma: during the first hour, pilocarpine solution is instilled every 15 minutes, 2-3 hours - every 30 minutes, 4-6 hours - every 60 minutes, and then 3-6 times a day, until the attack stops.
Secondary glaucoma (vascular, post-traumatic (burns)): 1-2 drops 2-4 times a day;
Primary open glaucoma: 1-2 drops 2-4 times a day in combination with β-blockers or other drugs that reduce intraocular pressure;
To constrict the pupil after installing mydriatics: 1-2 drops once.

Side effect

Headache (in the temporal and periorbital areas), short-term pain in the eye area; myopia; decreased vision, especially at dusk, due to the development of persistent miosis and spasm of accommodation; lacrimation, rhinorrhea, superficial keratitis; allergic reactions.
With long-term use, the development of follicular conjunctivitis, contact dermatitis of the eyelids and reversible clouding of the lens is possible.
System side effects rarely develop. Pilocarpine as an m-cholinergic mimetic can cause bronchospasm, slow heart rate, increase salivation, and rhinorrhea.
If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Interaction with other drugs

Antagonists of pilocarpine are atropine and other m-anticholinergic agents.
When used simultaneously with adrenomimetics, antagonism of action (on pupil diameter) may be observed.
Timolol and phenylephrine enhance the decrease in intraocular pressure, reducing the production of intraocular fluid.
It is possible to use pilocarpine in combination with sympathomimetics, β-blockers, and carbonic anhydrase inhibitors.
The M-cholinomimetic activity of pilocarpine is reduced by tricyclic antidepressants, phenothiazine derivatives, chlorprothixene, clozapine; enhanced by cholinesterase inhibitors.
It is possible to develop bradycardia and a decrease in blood pressure during general anesthesia with the use of halothane (in patients using pilocarpine eye drops).

special instructions

Release form.

Storage conditions

In a place protected from light, at a temperature not higher than 15 °C for the drug in tube droppers and dropper bottles, in a place protected from light at a temperature not higher than 25 °C for the drug in glass bottles. Keep out of the reach of children.

Best before date

3 years for the drug in vials; 2 years for the drug in dropper tubes and dropper bottles.
After opening the dropper tube, dropper bottle and bottle – 1 month.
Do not use after the expiration date stated on the package.

Vacation conditions

Marketing authorization holder/complaint receiving organization

Topic: Eye drops

Eye drops, lotions, ointments, and films are currently used to treat and prevent eye diseases. The latter are prepared only in pharmaceutical enterprises.

Eye drops are a liquid dosage form intended for instillation into the eye.

Eye drops can be solutions of medicinal substances obtained using sterile solvents approved for medical use (distilled water, isotonic buffer solutions, oils, etc.), or thin suspensions thereof.

Eye drops should be isotonic with tear fluid, but in some cases the use of hypertonic or hypotonic solutions is allowed.

Eye drops must be sterilized and tested to identify mechanical inclusions. During storage and transportation, eye drops must remain stable.

Similar requirements apply to eye lotions.

Technology for making eye drops and lotions.

1. Ensuring sterility is carried out by preparing eye drops and lotions under aseptic conditions (that is, they are prepared under the same conditions as medications for injections).

Solutions of thermostable substances (atropine sulfate, pilocarpine hydrochloride, zinc sulfate, ephedrine hydrochloride, etc.) are sterilized, as a rule, by the steam sterilization method at an excess pressure of 0.11 MPa (1.1 kgf/cm) at a temperature of 120 C. The sterilization time depends from physics - chemical properties medicinal substances, volume of solution, equipment used. Sterilization of eye drops and lotions is carried out in hermetically sealed, pre-sterilized bottles.

Solutions of thermolabile substances (resorcinol, physostigmine salicylate, etc.) are prepared under aseptic conditions without steam sterilization. In addition, they can be sterilized by filtration using membrane filters.

To maintain the sterility of eye drops and lotions after opening the package, preservatives (nipagin, nipazole, benzalkonium chloride, phenylethyl alcohol, chloroethane, etc.) can be added to their composition with the permission of the doctor.

2. Ensuring isotonicity and hypotonicity of solutions is carried out by adding sodium chloride, sodium nitrate or sodium sulfate to the eye drops (taking into account their compatibility with the other components of the solution).

Calculation of isotonic concentrations is carried out using isotonic equivalents of medicinal substances for sodium chloride, given in the “Table of isotonic equivalents for sodium chloride”. The amount of sodium chloride indicated in the "Table" (in grams) is equivalent to 1 g of the drug substance, since they form the same volume of an isotonic solution.

Example 1.

Take: Pilocarpine hydrochloride solution 1% 10 ml

Give. Label. 2 drops 3 times a day in both eyes

To make 10 ml of an isotonic solution from sodium chloride alone, 0.09 g of salt is required (isotonic concentration of sodium chloride 0.9%). According to the "Table", the sodium chloride equivalent of pilocarpine hydrochloride is 0.22. This means that 1 g of pilocarpine hydrochloride is 0.022 g of sodium chloride. Therefore, according to the recipe for sodium chloride, you need to take 0.09 g - 0.022 g = 0.068 g (0.07 g).

Passport: Pilocarpine hydrochloride 0.1 g

Sodium chloride 0.07 g

Water for injections 10 ml

_______________________________

Total volume 10 ml

To prepare the solution, 0.7 ml of 10% sodium chloride solution can be used. In this case, the amount of purified water will be 9.3 ml.

Under aseptic conditions, dissolve 0.1 g of pilocarpine hydrochloride and 0.07 g of sodium chloride in approximately 5 ml of water for injection in a sterile stand. The solution is filtered through a pre-washed sterile paper filter (or sterile glass filter No. 3) into a sterile neutral glass vial and the remaining amount of solvent is filtered through the same filter. The bottle with the solution is sealed with a sterile rubber stopper and inspected to identify mechanical inclusions (you can use the UK-2 device). If there are mechanical impurities, the solution is filtered again and checked again. The bottle is then sealed with a metal cap using a crimping device. When turning the bottle over, the solution should not flow out. Next, the bottle is tied with parchment paper, leaving a “tab” with an inscription about the name and concentration of the solution. The solution is sterilized by steam method at a temperature of 120º C for 8 minutes.

After sterilization, the solution is checked again to identify mechanical impurities, and the color quality of the closure is monitored. Then the bottle is decorated with a label Pink colour, which indicates the number of the pharmacy, prescription, date, surname and initials of the patient, method of administration. The warning labels “Store in a cool place away from light” and “Handle with care” are affixed. The bottle is sealed with sealing wax. write out a signature.

Example 2.

Take: Sulfacyl sodium solution 30% 10 ml

Give. Label. 2 drops every 3 hours in the left eye

Equivalent of sulfacyl - sodium according to sodium chloride 0.26. Therefore, 1 g of sulfacyl sodium is equivalent to 0.26 g of sodium chloride, and 3 g of sulfacyl sodium is equivalent to 0.78 g of sodium chloride. The sulfacyl sodium solution according to the prescription is hypertonic, since it is equivalent to a 7.8% sodium chloride solution (isotonic concentration of sodium chloride 0.9%).

3. Ensuring stability. Solutions of many medicinal substances used for eye diseases are stabilized. For these purposes, buffer solvents, antioxidants, complexones and other substances are used, depending on the properties of the components of eye drops and lotions.

Stabilizers and buffer solvents are used in the manufacture of eye drops according to standard prescriptions or as directed by a doctor.

The sodium sulfacyl solution (example 2) is stabilized by adding sodium thiosulfate (0.15%) and hydrochloric acid

(3.5 ml of 1 mol/l solution per 1 l).

Passport: Sulfacyl - sodium 3 g

Sodium thiosulfate 0.015 g

Hydrochloric acid solution

1 mol/l 0.035 ml

Water for injection 10 ml_

Total volume 10 ml

Dissolve sodium sulfacyl in approximately 5 ml of water for injection (its solubility in water is 1: 1.1), add solutions of sodium thiosulfate and hydrochloric acid (in drops in accordance with the labels on the bottles with solutions), filter, adding the rest of the water through the filter.

The solution is sealed, checked to identify mechanical impurities, sterilized and prepared in the same way as described in example 1.

Sulfacyl sodium belongs to list B substances, therefore bottles with its solution are not sealed. Stabilization of eye drops and lotions can significantly increase their shelf life.

4. Freeing eye drops and lotions from mechanical impurities by filtering. Filtration is carried out through sterile paper, glass (No. 3 and No. 4) filters and filters made of synthetic materials. The filters are first thoroughly washed with sterile distilled water.

Since eye drops are prescribed in small quantities

(10-15 ml), then when filtering them, significant losses of medicinal substances are possible, especially when filtering through paper filters. Therefore, it is recommended that when making them, the solvent is divided into parts, one of which is used to dissolve the substance, the other to wash off the substance adsorbed on the filter, as described in examples 1 and 2. The same technique should be used when filtering eye lotions, although their volume reaches 150 - 200 ml.

The inspection to identify mechanical inclusions is carried out in accordance with the instructions approved by the Ministry of Health of the Republic of Kazakhstan. If mechanical inclusions are detected, the solutions are re-filtered through a thoroughly washed filter.

5. Ensuring long-lasting action of eye drops. To prolong the action of medicinal substances used in the form of eye drops, synthetic high-molecular compounds are used: methylcellulose (0.5 - 1%), sodium - carboxymethylcellulose (up to 2%), polyvinyl alcohol

(1 - 2.5%), polyacrylamide (1 - 2%), etc. They are included in the composition of eye drops if manufactured according to standard prescriptions or as directed by a doctor.

6. Use of concentrated solutions of medicinal substances in the manufacture of eye drops and lotions. Due to the small concentrations and volumes of eye drops, difficulties often arise when weighing out medicinal substances. These solutions can be one or two component.

One-component concentrated solutions

Glucose 20%

Potassium iodide 10%

Calcium chloride 10%

Ascorbic acid 10%

Sodium chloride 10%

Sodium iodide 10%

Riboflavin 0.02%

Zinc sulfate 1%

Example 3.

Take: Zinc sulfate solution 0.25% 10 ml

Give. Label. 2 drops in both eyes 3 times a day

It is impossible to accurately weigh 0.025 g of zinc sulfate on a BP scale. There is a concentrated 1% solution of zinc sulfate (or 1:100). 2.5 ml of this solution contains 0.025 g of zinc sulfate. This solution is hypotonic, since 0.025 g of zinc sulfate creates the same osmotic pressure in the solution as 0.003 g of sodium chloride. Therefore, 0.087 g of sodium chloride or 0.87 ml of its concentrated solution should be added to the zinc sulfate solution. It would not be a mistake to add 0.9 ml of 10% sodium chloride solution, given that GF X allows fluctuations in the concentration of sodium chloride solution (0.7 - 1.1%).

Passport: Water for injections 6.6 ml

Zinc sulfate solution 4% -2.5 ml

Sodium chloride solution 10% - 0.9 ml

Total volume 10 ml

Under aseptic conditions, measure into a sterile vial using a sterile pipette.

6.6 ml sterile water for injection, 2.5 ml of concentrated zinc sulfate solution and 0.9 ml of concentrated sodium chloride solution. The resulting solution is sealed with a sterile rubber stopper, checked to identify mechanical impurities, the stopper is rolled with a cap, the quality of the seal is checked and issued with a pink label.

Example 4.

Take: Riboflavin solution 0.01% 10 ml

Ascorbic acid 0.03

Mix it up. Give. Label. 2 drops for both

eyes 3 times a day

The calculation of isotonicity (students do it) shows that the solution is hypotonic. It can be prepared with a 0.9% sodium chloride solution. 5 ml of a 0.02% solution of riboflavin contains 0.001 g of the substance, 0.3 ml of a 10% solution ascorbic acid contains 0.03 g of substance, 0.9 ml of 10% sodium chloride solution contains 0.09 g of substance. To obtain 10 ml of solution as prescribed, add 3.8 ml of water for injection.

Passport: Water for injections 3.8 ml

Riboflavin solution 0.02% - 5 ml

Ascorbic acid solution 10% - 0.3 ml

Sodium chloride solution 10% -0.9 ml

____________________________________

Total volume 10 ml

The solution is prepared similarly to that described in example 3.

When preparing a 1% suspension of hydrocortisone, which doctors prescribe in the form of eye drops, a ready-made 2.5% suspension of hydrocortisone acetate, intended for injection, can be used. A sterile isotonic sodium chloride solution is added to the calculated amount of suspension under aseptic conditions.

7. Packaging of eye drops and lotions must ensure stability and sterility during storage and transportation and, as a rule, have devices for instillation.

Store eye drops and lotions in a cool place, protected from light, unless otherwise indicated in private articles.

Section: Eye dosage forms.

Topic: Eye ointments

Eye ointments are a soft dosage form, prepared under aseptic conditions, used for eye diseases by placing behind the lower or upper eyelid

Manufacturing technology eye ointments. They are prepared similarly to dermatological ointments, but, of course, under aseptic conditions. Medicinal substances, soluble in water (including resorcinol and zinc sulfate), before mixing with the base, dissolve in sterile water for injection. Medicinal substances that are insoluble in water are thoroughly crushed with a sterile auxiliary liquid.

If the ointment prescription is standard, it is prepared on the basis specified in the prescription.

Example 1.

Take: Eye ointment 10.0

Give. Label. Apply to eyelid

Eye ointment is called mercury yellow ointment of the following

Mercury oxide yellow 2 g

Vaseline oil 2g

Vaseline 80 g

Lanolin anhydrous 16 g

Passport: Mercury oxide yellow 0.2 g

Vaseline oil 0.2 g

Vaseline 8 g

Lanolin anhydrous 1.6 g

_____________________________

Total volume 10

Vaseline (not containing reducing substances or the “eye ointment” grade), anhydrous lanolin, fats, oils must be sterile.

They can be sterilized by steam in hermetically sealed containers at a temperature of 120 C for 2 hours.

Vaseline, wax, fats, lanolin, mineral and vegetable oils They are also sterilized by the air method (dry hot air) at a temperature of 180 C or 200 C (Table 16).

The ointment is prepared as follows. Under aseptic conditions, in a sterile mortar, thoroughly grind 0.2 g of yellow mercury oxide with 0.2 g of sterile petroleum jelly (add drops in accordance with the inscription on the label) with a sterile pestle. Then sterile anhydrous lanolin and petroleum jelly are added in parts (they are pre-weighed onto sterile parchment paper capsules), constantly mixing the ointment. Then the ointment is transferred into a sterile glass jar and closed with a screw cap with a sterile parchment lining. Decorate the jar with a pink label “Eye ointment”. Attach warning labels “Keep away from light.”

The above base should be used in the preparation of 0.5% or 1% mercury yellow ointment.

If the prescription of the ointment is non-standard and the doctor does not indicate in the recipe what base to use, then for the production of eye ointments he recommends a mixture of 10 parts of anhydrous lanolin and 90 parts of Vaseline of the “eye ointment” grade. The mixture is melted, filtered and sterilized as above.

Table 16. Sterilization modes for fats and oils

Sample mass, g Temperature, C Minimum time, min

Up to 100 180º 30

101 - 500 180 40

101 - 500 200 20

Example 2.

Take: Zinc sulfate 0.005

Basics 20.0

Mix to make an ointment

Give. Label. Patch the eyelid

Passport: Zinc sulfate 0.05

Lanolin anhydrous 2 g

Vaseline 18 g

_______________________

Total weight 20.05 g

Under aseptic conditions, 0.05 g of zinc sulfate is dissolved in a sterile mortar in 2 - 3 drops of sterile water for injection (its solubility in water is 1: 0.075). Add to the solution, while stirring, in parts to ensure homogeneity. Packed and decorated in the same way as indicated in example 1.

Quality control. The quality of manufactured drops and lotions is checked in the same way as injection solutions, i.e. check the recipe, passport, packaging, closure, design, color, absence of mechanical inclusions, deviations in volume. Also, much attention is paid to the chemical analysis of eye drops and lotions. Complete before sterilization chemical analysis, after sterilization - selective. The sterility of eye drops and lotions is also selectively checked.

The volume of solution in the bottles must be within +/- 10% of what is indicated on the label (nominal).

The quality of eye ointments is assessed in the same way as dermatological ointments. Special attention pay attention to the uniformity of eye ointments.