M5.4-Manufacturing-Pharmacy.pdf

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 (