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    MANUF FO13

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    4 views9 pages

    Manuf Fo13

    Uploaded by

    deguzman2121160

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    Laboratory Guide for Manufacture of Drugs, Cosmetics and Veterinary Medicine Group no.: Product Name: CALCIUM CARBONATE TOOTHPASTE Shelf Life: 1 year Manufacturing Order No. Batch Size: 25 grams Finishing Order No: Date of Manufacture: Batch Number: Expiry Date: Objectives: 1, To manufacture Calcium carbonate Toothpaste by Levigation in compliance to cGMP standards. 2. To label the finished product according to FDA requirements. Materials: Evaporating Dishes Mortar and Pestle Watch Glasses Waxed paper Spatula (metal and porcelain) Mettler PE Analytical Balance Graduated cylinder, 50 mL. Collapsible tube, 25 mL Test tubes Packing and Labeling Materials Pipets, 10 mL, 5, mL, 1 mL Aspirator Formulation for 25 grams: Precipitated Calcium carbonate, USP ‘Soap flakes Xylitol - Glycerin, (to make a thick paste) Peppermint oil ~ oa 4 drops gs ad ~ 25 grams ‘A. Dispensing Procedure: 41. Weigh the following; calcium carbonate, soap flakes, and xylitol. Measure the following; glycerin and Dispensed by: peppermint oil Checked by: ‘EU School of Pharmacy — 86[Page Laboratory Guide for Manufacture of Drugs, Cosmetics and Veterinary Medicine B. Compounding Procedures: 2. Ina mortar, triturate together precipitated calcium Done by: carbonate and soap flakes. Checked by: 3. Gradually add glycerin to the powdered mixture. With the use of the pestle, levigate the mixture Done by: _ Until the mixture is free from lumps. Checked by: 4, Incorporate xylitol and continue levigation to Done by: produce a smooth paste. Checked C. Packaging Procedures: 5. Fill the product in a clean, previously tared Filled by: collapsible tube. Checked 6. Crimp and seal the opening of the tube. Determine the gross weight and Sealed by: net weight of the contents. Checked by: - 7. Affix the label on tube and place the finished Finished by: product in the unit box Checked by: | Each gram contains: grams | Lot no Date Mfa: Calcium Brand name Expiry Date: Carbonate Xylitol — TOOTHPASTE Ina suitably flavored base. ‘Aids in the prevention of | FOR EXTERNAL USE dental cavities Storage: WARNING: Manufactured by: Store at a temperature Keep out of reach of not exceeding 40°C. children below 6 years Company Name CEU Mendiola, Manila | Protect from freezing, “CEU School of Pharmacy 71 Laboratory Guide for Manufacture of Drugs, Cosmetics and Veterinary Medicine DISCUSSION: Toothpaste is a paste or gel dentifrice used with a toothbrush as an accessory to clean and maintain the aesthetics and health of teeth. Toothpaste is used to: 1. promote oral hygiene 2. serve as an abrasive that aids in removing the dental plaque and food from the teeth 3. assists in suppressing halitosis 4, delivers active ingredients such as fluoride or xylitol to help prevent tooth and “ gum disease (gingivitis) lost of the cleaning is achieved by the mechanical action of the toothbrush, and not by the toothpaste, Salt and sodium’bicarbonate (baking soda) are among materials that can be substituted for commercial toothpaste. — Toothpaste is not intended to be swallowed, but is generally not very harmful if accidentally swallowed in small amounts. Toothpaste Formulation Components: In addition to 20-42% water, toothpastes are derived from a variety of components, including three main ones: abrasive 4, fluoride 2. detergents rasives brasives constitute at least 50% of a typical toothpaste. These insoluble particles help remove plaque from the teeth:“The removal of plaque and calculus helps minimize cavities and periodontal diseases. Representative abrasives include particles of aluminum hydroxide (AKOH)s), calcium carbonate (CaCO;), various calcium hydrogen phosphates, various silicas and zeolites, and hydroxyapatite (Cas(PO«)sOH). ‘Abrasives, like the dental polishing agents used in dentists’ offices, also cause a ‘small amount of enamel erosion, which is termed "polishing" action. Some brands contain powdered white mica, which, acts as a mild abrasive, and also adds a cosmetically pleasing glittery shimmer to the paste. ‘CEU School of Pharmacy aB/Page Laboratory Guide for Manufacture of Drugs, Cosmetics and Veterinary Medicine The polishing of teeth removes stains from tooth surfaces, but has not been shown to improve dental health over and above the effects of the removal of plaque and calculus. Fluorides x Fluoride in various forms is the most popular active ingredient in toothpaste to prevent cavities. Fluoride occurs in small amounts in plants, animals, and some natural water sources. The additional fluoride in toothpaste has beneficial effects on the formation of dental -enamel and bones. Sodium fluoride (NaF) is the most common source of fluoride, but stannous fluoride (SnF2), olaflur(an organic salt © of _—fluoride), and sodium monofiuorophosphate (NazPOsF) are also used.

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