PREP 8 Calamine- Phar Cen PDF

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INTERNATIONAL SCHOOL OF ASIA AND THE PACIFIC- KALINGA COLLEGE OF PHARMACY

PREPARTION NO. 8 TITLE OF EXPERIMENT: CALAMINE LOTION, USP

I. OBJECTIVE: To prepare Calamine Lotion.

II. MATERIALS: Beaker Digital Balance Funnel

Mortar and pestle Spatula Stirring rod

Watch glass Graduated Cylinder

III. FORMULATION: based on this formulation prepare only 80 mL Calamine……………..............80 g Zinc oxide……………………..80 g Glycerin……………………….20 mL Bentonite magma…………….400 mL Calcium hydroxide Solution qs To make 1000mL IV. COMPOUNDING PROCEDURE: 1. Weigh/Measure the needed ingredients accurately. 2. Dilute the bentonite magma with an equal volume of Calcium Hydroxide solution. 3. Mix the calamine powder and zinc oxide powder intimately in a mortar with the glycerin and 100 ml of the diluted magma 4. Triturate until smooth, uniform paste is formed. 5. Gradually incorporate the remainder of the diluted magma. 6. Finally add enough Calcium Hydroxide solution to make 1000ml. 7. Shake well. 8. Place in an appropriate container. 9. Label the container properly V. QUESTIONS FOR RESEARCH: 1. What are lotions? 2. How are lotions prepared? 3. How are lotions applied? 4. What is the auxiliary label for this product? VI. CALCULATIONS. SHOW SOLUTION ON HOW TO REDUCE THE FORMULATION. Prepare only 80mL

GROUP NAME: PHARCEN DATE PERFORMED: AUGUST 14,2021 WRITTEN REPORT SCORE:

PRODUCT SCORE: ___ RESEARCH SCORE:

CALAMINE LOTION, USP A.

PRODUCT INFORMATION SHEET. Synonyms/ Latin Names

Therapeutic classification

Indication

•Soothing Lotion •Zinc ointment •Lotion Calaminae •Iron Oxide with Zinc Oxide lotion •Antipruritic (anti-itching agent (treat the itchiness caused by sunburn, eczema, rashes, chickenpox, insect bites, stings) •Astringent •Astringent, antipruritic •used as a topical protectant •soothing lotion to sunburn •treatment for ivy poisoning; Insect bites and stings; chicken pox marks

Description of the Finished Product

Usually are fluid, somewhat viscid suspension dosage forms for external application to the skin. Method(s) of Preparation Used 1. Dilute 2.5 mL Bentonite Magma with an equal volume of Calcium Hydroxide Topical Solution. 2. Mix the powders intimately with the 0.2 mL Glycerin and about 1 mL of the diluted magma 3. Triturating until a smooth, uniform paste is formed. RFIS: Intimately mix ingredients to form uniform particle size. 4. Gradually incorporate the remainder of the diluted magma. RFIS: To prevent air from being incorporated (solidifies diluted magma) 5. Finally add enough Calcium Hydroxide Topical Solution to make 10 mL, and shake. Appropriate Container for the Product 15 mL clean flint bottle nowadays in sachets, plastic containers Storage Condition •Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. •Keep out of the reach of children. •Do not keep outdated medicine or medicine no longer needed. Amount of Product Prepared 80 mL Calculations for Formula Adjustment TO FORMULATE 80 mL Calamine 80 g Zinc oxide 80 g Glycerin 20 mL Bentonite magma 400 Ml Calcium hydroxide Solution To make 1000Ml Factor(F)= __amount desired_ Amount of formula Factor(F)= __80 mL__= 0.08 1000mL

solution conti’d: ×0.08 Calamine 80 g 6.4 g Zinc Oxide 80 g 6.4 g Glycerin 20mL 1.6 mL Bentonite magma 400mL 32 mL Calcium hydroxide Solution 1000mL to make 80 mL

B.

PRODUCT FORMULATION SHEET INGREDIENT Calamine

Zinc Oxide Glycerin

Bentonite Magma

Calcium Hydroxide solution

C.

USE IN THE FORMULA Active ingredient; Gives the anti-pruritic action

PHYSICAL DESCRIPTION It is a mixture of zinc oxide and iron oxide. Due to the presence of iron oxide calamine is pink in color; solid powder Gives the astringent action It is a white powder that is insoluble in water Humectant, emollient, wetting agentIt is a colorless or pale-yellow liquid; odorless and syrupy; sweet and warm taste. Stabilizing and suspending agent Crystalline, clay like mineral. Odorless, pale buff, or cream to grayish-colored fine powder, which is free from grit. Astringent action, dispersion Obtained by the action of water on medium; calcium oxide, also called slaked is used as it dissolves both zinc lime; aqueous solution oxide and bentonite magma. Has a white, powdery appearance in its solid-state

LABELING INFORMATION (Attach Product Label)

COMPOSITIONS: Calamine………………………..6.4 g Zinc oxide……………………….6.4 g Glycerin…………………………1.6 mL Bentonite magma………………32 mL Calcium Hydroxide solution....1000mL

INDICATIONS: -skin protectant -treatment for ivy poisoning, -insect bites, chicken pox marks and stings. -soothing lotion to sunburn

Mfg. lic. No.:ljjjj/2021 Batch No.: 1670 Mfg. Date: August 2021 MRP. Rs 55 (inclusive of all taxes)

CALAMINE LOTION ( Cal ami neTopi cal Suspensi on USP) 80mL

WARNINGS:

STORAGE Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

MANUFACTURED BY: PharCen

D. ANSWERS TO QUESTIONS FOR RESEARCH 1. What are lotions? • Lotions Either liquid or semi liquid preparations that contains one or more active ingredients in an appropriate vehicle. May contain antimicrobial preservatives and other appropriate excipients such as stabilizers. • Lotions are emulsions or suspensions generally in an aqueous vehicle, although certain solutions have been designated as lotions because of either their appearance or application. • Lotions are light-weight, non-greasy, and has low viscosity due to lower water content • Lotions are used as moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations such as rash and skin burns from radiation therapy. 2. How are lotions prepared? Lotions are usually liquid suspensions or dispersions intended for external application to the body. They may be prepared by: • Triturating the ingredients to a smooth paste and then cautiously adding the remaining liquid phase or in larger quantities by the use of high-speed mixers or homogenizers. Classical example is the Calamine Lotion, which consists of finely powdered insoluble solids held in more or less permanent suspension by the presence of suspending agents and/or surface active-agents. •By chemical interaction in the liquid. Example – White Lotion which must be freshly prepared and does not contain a suspending agent. The second type of lotion recognized by the USP XVII is the O/W type stabilized by a surface active-agent. Example of this is Benzyl Benzoate Lotion.

3. How are lotions applied? •Lotions are applied to external skin with bare hands, a brush, a clean cloth, or cotton wool. •Lotions are applied to where friction may occur (under arm pits, thighs ect.) •Lotions should be applied on damp skin right after showering. This is especially helpful if we use a hot shower because this can tend to dry out skin even more. You can also choose to apply body lotion after applying oil to your skin if your skin feels dry. Also, you can use it post-shaving to prevent the freshly exposed skin from getting dry as well as calm any razor bumps or irritation.

4. What is the auxiliary label for this product? Active Ingredient: Calamine and Zinc oxide Purpose Skin protectant Uses dries the oozing and weeping o poison ivy, Insect bites and stings Chicken pox marks Warnings For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.

Ask a doctor before using on chilren 6 months of age. When using this product Discontinue use if condition worsens or does not improve within 7 days and consult a doctor. Keep out of reach of children In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately. Directions Adults and children 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry before each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort. Children under 6 months of age: Consult a doctor before use. Other information Store at room temperature 13-30C (50-86F) Inactive ingredients Bentonite magma, calcium hydroxide, glycerin, purified water.

REFERENCES: https://www.slideshare.net/ammarabatool2/ointment-creams-and-lotions OINTMENTS, CREAMS AND LOTIONS https://en.wikipedia.org/wiki/Lotion LOTIONS https://www.kleinmd.com/blog/moisturizing-101-cream-vs-lotion

E. EVALUATION GROUP NAME BANG-I, GERALDINE CALLUENG, C. DALE DUMAGDAG, CRIZA JAVIER, AILYN

MENDOZA, J. KATE

TOLENTINO, SANDY

FUNCTION

SUBMITTED TO: ARCHIMEDES O. BAYQUEN, RPh, MPH Laboratory Instructor

REMARKS

CALCULATIONS PART, ANSWERS TO COMPLETED QUESTIONS FOR RESEARCH ANSWERS TO QUESTIONS FOR COMPLETED RESEARCH, CALCULATIONS PART ANSWERS TO QUESTIONS FOR DID NOT PARTICIPATE OR DID NOT RESEARCH, CALCULATIONS PART DO HIS/ HER PART PRODUCT INFORMATION SHEET AND COMPLETED PRODUCT FORMULATION, ANSWERS TO QUESTIONS FOR RESEARCH, RESEARCHER LEADER/ COMPILER, PRODUCCT COMPLETED INFORMATION SHEET AND PRODUCT FORMULATION, LABELLING OF PRODUCT, QUALITY ASSURANCE, RESEARCHER DID NOT PARTICIPATE OR DID NOT ANSWERS TO QUESTIONS FOR RESEARCH, PRODUCT FORMULATION DO HIS/ HER PART SHEET

GRADING Rubrics:

GROUP NAME

SCORE

COMPLETENESS AND ACCURACY OF DATA AND INFORMATION 55 POINTS  PRODUCT INFORMATION SHEET- 10 POINTS  PRODUCT FORMULATION SHEET- 10 POINTS  LABELING INFORMATION- 15 POINTS  ANSWERS TO QUESTIONS- 20 POINTS QUALITY OF OUTPUT 15 POINTS TIMELINESS OF SUBMISSION 10 POINTS INDIVIDUAL CONTRIBUTION OF EACH STUDENT 15 POINTS REFERENCES AT LEAST 3 CITATIONS 10 TOTAL 100 POINTS

REMARKS...