Manufacturing Pharmacy M5.4 PDF
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Mr. Darwin I. Carrido
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This document provides a concise explanation of the manufacturing process of tablets, from the essential ingredients (granulating agents, flow activators) to the auxiliary equipment and classifications of tablet presses. The document also mentions various types of tablets and their delivery systems.
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MANUFACTURING PHARMACY Examples: Lactose, Spray Dried Lactose, Starch, Types 3. EQUIPMENT...
MANUFACTURING PHARMACY Examples: Lactose, Spray Dried Lactose, Starch, Types 3. EQUIPMENT Dextrose, Mannitol, Sorbitol, Glucose, Sucrose, Avicel, o Intragranular Disintegrant Tablet Compression Machines MR. DARWIN I. CARRIDO Dibasic Calcium Phosphate Dehydrate, Calcium § Disintegrants that are mixed with other ingredients Auxiliary Equipment APRIL 2024 Carbonate, Cellulose prior to granulation and thus be incorporated within Tablet Press Classifications Transcriber: WEBSTER B. SALITA U Lactose is not indicated for patients with lactose the granules Legends: intolerant. It is not usually preferred by manufacturers but o Extragranular Disintegrant 3.1 TABLET COMPRESSION MACHINES U Side Notes still can be used in the formulation. § Disintegrant is mixed with the dry granules before Because tablets are made by “compression”, the (l ) Commonly asked in the Boards U Starch is inert and usually used by manufacturers. the complete powder mix is compacted stamping machines are called presses. (Lachman, U Dextrose, and Mannitol are intended to be used in Lieberman, & Kanig, 1987, p. 303) chewable tablets. Sorbitol, Glucose, and Sucrose are not MANUFACTURE OF TABLETS indicated for patients with DM. Basic Components: TABLETS are solid dosage forms prepared by compression U Calcium can catalyze the degradation of API and o Hopper – For holding and (hard tablets) or molding (soft tablets) that contains medicinal incompatibility with Chelating Agents. feeding granulation to be substances (API) with / without suitable excipients and/or other U Make sure that the excipients are inert (compatible compressed. pharmaceutical adjuncts. (Allen, Popovich, & Ansel, 2011) with other ingredients). It should not interfere the BA of o Dies – Define the size and Types of Tablets the API and should not affect the QC test result of the shape of the tablet. o According to Process of Manufacture product. o Punches – For compressing § Compressed, Molded, Hypodermic, Dispensing, Coated granulation within the dies. o According to Delivery System 2.2 ESSENTIAL: GRANULATING AGENT o Cam Tracks – For guiding § Immediate-Release (Oral), Chewable, Buccal, the movement of the AKA Binder or Adhesive Mechanisms of Action (MOA) punches. Sublingual, Vaginal, Extended-Release (ER) Substance that “glue” powders together and cause them o Wicking o According to Content Functions to form granules § Facilitate water uptake: Facilitates transport of § Effervescent 3.2 AUXILIARY EQUIPMENT Added to a drug-filler mixture to ensure that granules and liquids into the pores of the tablet to form smaller Sodium Bicarbonate (NaHCO3) – AKA Baking Soda – Granulation Feeding Device tablets can be formed with the required mechanical fragments Systemic Alkalizer and causes effervescence. o Forces granules into die cavity strength o Swelling § Instantly Disintegrating (e.g. Risperidone) Tablet Weight Monitoring Devices Examples: Water, Alcohol, Starch Paste, Acacia § Facilitates rupture of the tablet: Swelling of the o Monitors force at each compression station Mucilage, Gelatin Solution, Tragacanth Mucilage, disintegrant particles during sorption of water A. PROCESS of MANUFACTURE: COMPRESSED Tablet Deduster Sucrose Solution, Methylcellulose Solution, Sodium CMC Compressed tablets are manufactured with tablet 2.5 LESS ESSENTIAL: COLORANT o Removes excess powder Solution, PVP Solution, Sorbitol machines capable of exerting great pressure in U Acacia Mucilage is not an option because the color is Fette Machine Disguising of off-color drugs, product identification, and o Chills the compression components to allow the compacting the powdered or granulated material (much not good (brown color) and easily gets bad (also production of a more elegant product more compressible). Tragacanth). compression of low melting point substance such as Examples: FD&C & D&C dyes (applied in solutions), waxes Multiple compressed tablets – multiple layers U Most common is Starch as a Starch Paste because it Lakes (dyes that have been absorbed on a hydrous cheap, economic, accessible, and produced in PH. oxide and employed as dry powders for coloring) 1. MANUFACTURING 3.3 TABLET PRESS CLASSIFICATIONS 2.3 ESSENTIAL: FLOW ACTIVATOR / ANTIFRICTIONAL AGENT Single Press Lubricant o AKA Eccentric Press o Acts between surfaces in relative motion to prevent o Output: 200 tablets per minute friction and wear o Production of small batches of tablets during o Examples: Magnesium stearate (