Product Manufacturing Practicum Eye Drops | The University of Tennessee at Martin - Edubirdie

University:
The University of Tennessee at Martin
Course:
PHCY 1213 | Pharmacy Law I
Academic year:

2024
Views:

123

Pages:

3
Author:

nicho hem

PRODUCT MANUFACTURING PRACTICUM EYE DROPS I. FORMULA Atropine Sulfate 1% Eye drops in 10 ml bottle no. II. SPECIFICATION A. Efficacious Ingredients: Atropine Sulfate Description: Solubility: Melting/melting point: B. Dosage Usual dose : Max dose : Dosage calculation: C. Medication List Potent drug D. Medicinal preparations Description : Clear solution Stability OTT : alkali, tannic acid, mercury salt pH : 3.5-6 Preservative : : Benzalkonii Chloridum 0.01% Antioxidant : Stabilizer: Dinatrii edetas 0.05% (Chelating Agent) E. Tonicity: Completeness Substance ∆tb C Atrophin sulfate 0.073 1 Benzalkonii Chloridum 0.091 0.01 Dinatrii Edetas 0.132 0.05 Tonicity Calculation W= W= W= To make the solution isotonic, add as much NaCl. . . . . . . . . . . . . % (w/v) III. STERILIZATION A. Tools and Materials Tool Sterilization Time Beaker glass Oven 170°C 30' Funnel & filter paper Autoclave 121°C 15' Eye drop bottle Oven 170°C 30' Watch glass Direct fire 20” Metal spatula Direct fire 20” Stirring rod Direct fire 20” Eye drop pipette Autoclave 121°C 15' Syringe Autoclave 121°C 15' Initials B. Preparations Sterilized using sterilization method A or C and immediately cooled (Fornas 2, 32) IV. COMPLETE FORMULA Atropine Sulfas 1% Benzalkonium Chloridum 0.01% Natrii Chloridum . . . . . . . . . . . % Dinatrii Edetas 0.05% Aqua pro injectionum ad 10ml V. WEIGHING Material Basic Unit 10 ml Atropine sulfate 100mg NaCl . . . . . . . . mg Dinatrii Edetas 5mg Benzalkonium 1mt Chloridum VI. PROCESSING No. Processing Initials 1. Dissolve Atropine sulfas in part of the fire Production Volume Initials 2. Dissolve NaCl in part of the fire 3. The two mixtures are mixed 4. Add benzalkonium chloridum solution 5. Add Dinatrii Edetas solution 6. The solution is added on fire until it approaches the final volume, check pH = ............ 7. The solution was added to the fire ad ........ ml 8. The solution is filtered and the first filtrate is discarded 9. Collect the atropine solution using a bacterial filter and put it into a 10.5ml eye drop bottle aseptically (final sterilization)

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