Laboratory Guide for Manufacture of Drugs, Cosmetics and Veterinary Medicine Group no. Company Name Name: 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 Cal Soap flakes —- Xylitol — Glycerin, (to make a thick paste) Peppermint oi ———-——--— 4 drops qs ad ~ 25 grams A. Dispensing Procedure: 4. Weigh the following; calcium carbonate, soap flakes, and xylitol. Measure the following; glycerin and Dispensed by: peppermint oil Checked by: ‘CEU School of Pharmacy [PageLaboratory Guide for Manufacture of Drugs, Cosmetics and Veterinary Medicine B. Compounding Procedures: 2. Ina mortar, triturate together precipitated calcium carbonate and soap flakes. 3. Gradually add glycerin to the powdered mixture. With the use of the pestle, levigate the mixture Until the mixture is free from lumps 4. Incorporate xylitol and continue levigation to produce a smooth paste. C. Packaging Procedure: 5. Fill the product in a clean, previously tared collapsible tube. 6. Crimp and seal the opening of the tube. Determine the gross weight and et weight of the contents. 7. Affix the label on tube and place the finished product in the unit box. Each gram contains: grams Calcium Brand name Carbonate —~ Xylitol — TOOTHPASTE Ina suitably flavored base. Aids in the prevention of dental cavities WARNING: Manufactured by: Keep out of reach of children below 6 years ‘Company Name of age. CEU Mendiola, Manila CEU School of Pharmacy Done by: Checked by: Done by: Checked by: Done by: Checked by: Filled by: Checked by Sealed by: Checked by: Finished by: Checked by: Lot no.: Date Mf: Expiry Date: FOR EXTERNAL USE Storage Store at a temperature not exceeding 40°C. Protect from freezing a ~87[Page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 assists in suppressing halitosis, delivers active ingredients such as fluoride or xylitol to help prevent tooth and gum disease (gingivitis) a. 4 Most 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: {n addition to 20-42% water, toothpastes are derived from a variety of components, including three main ones. abrasive 1, fluoride 2. detergents Abrasives Abrasives constitute at least 50% of a typical toothpaste. Th hese 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 (Al(OH)s), calcium carbonate (CaCO;), _various calcium hydrogen phosphates. various silicas and zeolites, and hydroxyapatite (Cas(PO,),0H) 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 88 [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. 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 monofluorophosphate (NazPOsF) are also used Stannous fluoride has been shown to be more effective than sodium fluoride in reducing the incidence of dental caries and controlling gingivitis. Surfactants Many, although not all, toothpastes contain sodium lauryl sulfate (SLS) or related surfactants (detergents). SLS is found in many other personal care products, as well, such as shampoo, and is mainly a foaming agent, which enables uniform distribution of toothpaste, improving its cleansing power Antibacterial agents Triclosan, an antibacterial agent, is a common toothpaste ingredient, Triclosan or zine chloride prevent gingivitis and, according to the American Dental Association, helps reduce tartar and bad breath ‘A 2006 review of clinical research concluded there was evidence for the effectiveness of 0.30% triclosan in reducing plaque and gingivitis. Flavorants Toothpaste comes in a variety of colors, and flavors intended to encourage use of the product. Three most common. flavorants are peppermint, spearmint, and_ wintergreen. Toothpaste flavored with peppermint-anise oil is popular in the Mediterranean region. The respective oils, e.g. peppermint oll, provide these flavors. CEU School of Pharmacy wlPageLaboratory Guide for Manufacture of Drugs, Cosmetics and Veterinary Medicine Anise, apricot, bubblegum, cinnamon, fennel, lavender, neem, ginger, vanilla, 'emon, orange, and pine are some of the exotic flavors used in some toothpaste formulations. Unflavored toothpastes also exist. Remineralizers Hydroxyapatite nanocrystals and calcium phosphate are included in some formulations for remineralization, i. the reformation of enamel Miscellaneous components Agents are added to suppress the tendency of toothpaste to dry into a powder. Included are various sugar alcohols, such as glycerol, sorbitol, or xylitol, or related derivatives, such as 1,2-propylene glycol and polyethylene glycol ‘Strontium chloride or potassium nitrate is included in some toothpastes to reduce sensitivity, Sodium polyphosphate is added to minimize the formation of tartar. Other Types of Toothpastes White toothpastes Many toothpastes make whitening claims. Some of these toothpastes contain peroxide, the same ingredient found in tooth bleaching gels. The abrasive in these toothpaste remove the stains, not the peroxide. Whitening toothpaste cannot alter the natural color of teeth or reverse discoloration by penetrating surface stains or decay. To remove surface stains, whitening toothpaste may include abrasives to gently polish the teeth, and/or additives such as sodium tripolyphosphate to break down or dissolve stains. When used twice a day, whitening toothpaste typically takes two to four weeks to make teeth appear whiter. Whitening toothpaste is generally safe for daily use, but excessive use might damage tooth enamel. Teeth whitening gels represent an alternative ‘CEU Schoo! of Pharmacy B0]PageLaboratory Guide for Manufacture of Drugs, Cosmetics and Veterinary Medicine Herbal and “natural” toothpastes Herbal toothpastes are made from natural ingredients and some are even certified as organic. Many consumers have started to switch over to natural toothpastes to avoid synthetic and artificial flavors that are commonly found in regular toothpastes. Due to the increased demand of natural products, most of the toothpaste manufacturers now produce herbal toothpastes. This type of toothpaste does not contain dyes and artificial flavors. Many herbal toothpastes do not contain fluoride or SLS. The ingredients found in natural toothpastes vary widely but often include baking Soda, aloe, eucalyptus oil, myrrh, plant extract (strawberry extract), essential oils. |n addition to the commercially available products, it is possible to make one's own toothpaste using similar ingredients, CEU School of Pharmacy [Page