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Commercially available in an acceptable grade in all countries. Low cost. Physiologically inert. Must be color-compatible(not produce any off color appearance). No deleterious effect on the bioavailability of the drugs in the product. What is direct compression : What is direct compression Direct compression (DC) is the tabletting of a blend of ingredients i.e. the compression mix, without a preliminary granulation or aggregation process. The compression mix contains the active pharmaceutical ingredient (API) blended with one or more excipients. The excipients may include binders, fillers/diluents, disintegrant and lubricants. advantages of dc : advantages of dc Direct compression is economic compare to wet granulation since it requires fewer unit operations. Due to fewer unit operations, the documentation and validation requirements are reduced. It requires less equipment, lower power consumpation less space, less time and less labor leading to reduce production cost of tablets. More suitable for moisture and heat sensitive APIs, since it eliminates wetting and drying steps. Disadvantages of dc : Disadvantages of dc Direct compression is more prone to segregation because of the difference in the density of the API and excipients. The dry state of the material during mixing may induce static charge and lead to segregation. due to this problems like weight variation and content uniformity may occur. APIs that have poor flow properties and low bulk density is difficult to process by direct compression. Directly compressible excipients are costly because these are prepared by spray drying, fluid bed drying, roller drying or co-crystallization. Examples of dcv : Examples of dcv Lactose Lactose derivatives Starch Cellulose derivatives Sugar and sugar alcohal sucrose dextrose sorbitol mannitol maltodextrin lactose : lactose Lactose produced from whey, as a by product of cheese and casein production. Lactose present in different polymorphs depending on the crystallization conditions. Most popular as a tablet filler due their cost and their availability. Lactose derivatives : Lactose derivatives α-lactose monohydrate:- It is hard crystal. Non hygroscopic. Excellent physical and chemical stability. Good water solubility. Poor binding property. Good flowability. Slide 10: Spray dried lactose:- Less brittleness than α-lactose monohydrate. Low hygroscopicity. Good flowability. Agglomerated lactose also used in the direct compression. It is granulated form of α-lactose monohydrate.It has good binding property. starch : starch Good compactability. Better flow. Starch -1500 is more fluid than starch.It retains the disintegrant properties of starch without decreasing the flow a compactability of the formulation. High moisture content 12-13%. Accelerate the decomposition of moisture sensitive drugs. Used as DC filler disintegrant. Lubricant sensitive. Cellulose derivatives : Cellulose derivatives Microcrystalline cellulose(MCC):- Purified partially depolymerized cellulose. White, crystalline powder. Odourless, tasteless. Low compressibility. Better flowability. Easy availability. Hydroxy propyl cellulose and ethyl cellulose are also used as a diluents. Sugar and sugar alcohal : Sugar and sugar alcohal Sucrose :- Used as a filler in tablets. Used as co-crystallized sucrose with 3% modified dextrin. Good flow properties. Need glidant only above 50% relative humidity. Excellent color stability. Slide 14: Dextrose :- It is crystallized dextrose contains 3-5% maltose. Moisture content 9%. Available in both anhydrous and hydrous product. Highly compatible. At 75% relative humidity it becomes quite hygroscopic. Slide 15: Sorbitol :- Affect the compactability and stability. Moisture content 0.5-2%. Mostly used in chewable tablets. It has cool taste so used in ‘sugar free’ mints. It is hygroscopic. Need of lubricant when moisture content exceeds 2% in formulation. Slide 16: Mannitol :- It is used where complete solubility is required. It is costly. Used as a filler in chewable tablets. It is non-hygroscopic. It also has cooling mouth feel. β-mannitol is commercially available as Parteck® Slide 17: Maltodextrin :- It is highly compactible. Completely soluble. Low hygroscopicity. It is free flowing agglomerated maltodextrin available as Maltrin® Brand name of diluents : Brand name of diluents Used for direct compression Slide 19: references : references Angsburger LL. Pharmaceutical Dosage Forms- Tablet Rational Design & Formulation 3rd edition. Lachmann L, Joseph l. kanig, Libermann H.The theory and practice of Industrial Pharmacy,3rd edition, Varghese publishing house 1991, p. 325-26. Patel RP, Bhavsar M, S.K. College of Pharmaceutics & Pharma; International Journal of PharmTech Research; Directly Compressible Materials via Co-Processing, Vol. 1, no. 3, pp 745-753; July-sept 2009. Thank you : Thank you You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.