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Published on February 24, 2018

Author: koshish23


PROCESSING OF TABLETS: By : Dr. K.B.Gabhane Assistant Professor Department of Pharmaceutical Chemistry, Vidyabharti College of Pharmacy, Amravati PROCESSING OF TABLETS DEFINATION: DEFINATION According to the Indian Pharmacopoeia : Pharmaceutical tablets are solid, flat or biconvex dishes, unit dosage form, prepared by compressing a drugs or a mixture of drugs, with or without diluents. They vary in shape and differ greatly in size and weight, depending on amount of medicinal substances and the intended mode of administration. Advantages: Advantages They are unit dosage form and offer the greatest capabilities of all oral dosage form for the greatest dose precision and the least content variability. Cost is lowest of all oral dosage form. Lighter and compact Easiest and cheapest to package and strip. Easy to swallowing with least tendency for hang‐up. Sustained release product is possible by enteric coating Objectionable odour and bitter taste can be masked by coating technique. Suitable for large scale production. Greatest chemical and microbial stability over all oral dosage form. Product identification is easy and rapid requiring no additional steps when employing an embossed and/or monogrammed punch face. Disadvantages of Tablet dosage form are: Disadvantages of Tablet dosage form are 1 . Difficult to swallow in case of children and unconscious patients. 2. Some drugs resist compression into dense compacts, owing to amorphous nature, low density character. 3. Drugs with poor wetting, slow dissolution properties, optimum absorption high in GIT may be difficult to formulate or manufacture as a tablet that will still provide adequate or full drug bioavailability. 4. Bitter testing drugs, drugs with an objectionable odor or drugs that are sensitive to oxygen may require encapsulation or coating. In such cases, capsule may offer the best and lowest cost. General properties of Tablet dosage forms:: General properties of Tablet dosage forms: A tablet should have elegant product identity while free of defects like chips, cracks, discoloration, and contamination. 2. Should have sufficient strength to withstand mechanical shock during its production packaging, shipping and dispensing. 3. Should have the chemical and physical stability to maintain its physical attributes over time 4. The tablet must be able to release the medicinal agents in a predictable and reproducible manner. 5. Must have a chemical stability over time so as not to follow alteration of the medicinal agents. Slide 7: (A) Tablets ingested orally: Compressed tablet, e.g. Paracetamol tablet Multiple compressed tablet Repeat action tablet Delayed release tablet, e.g. Enteric coated Bisacodyl tablet Sugar coated tablet, e.g. Multivitamin tablet Film coated tablet, e.g. Metronidazole tablet Chewable tablet, e.g. Antacid tablet (B) Tablets used in oral cavity: Buccal tablet, e.g. Vitamin‐c tablet Sublingual tablet, e.g. Vicks Menthol tablet Troches or lozenges Dental cone Slide 8: (c) Tablets administered by other route: 1. Implantation tablet 2. Vaginal tablet, e.g. Clotrimazole tablet (D) Tablets used to prepare solution: 1. Effervescent tablet, e.g. Dispirin tablet (Aspirin) 2. Dispensing tablet, e.g. Enzyme tablet ( Digiplex ) 3. Hypodermic tablet 4. Tablet triturates e.g. Enzyme tablet ( Digiplex ) Tablet Ingredients: Tablet Ingredients In addition to active ingredients, tablet contains a number of inert materials known as additives or excipients. Different excipients are: . Excipients 1 Diluent 2 Binder and adhesive 3 Disintegrents 4 Lubricants and glidants 5 Colouring agents 6 Flavoring agents 7 Sweetening agents Granulation technology on large scale by various techniques: Granulation technology on large scale by various techniques Direct Compression Process: Direct Compression Process Wet Granulation Process: Wet Granulation Process Tablet Compression Machine: Tablet Compression Machine Tablets are made by compressing a formulation containing a drug or drugs with excipients on stamping machine called presses. Tablet presses are designed with following basic components: 1) Hopper for holding and feeding granulation 2) Dies that define the size and shape of the tablet 3) Punches for compressing the granulation within the dies 4) Cam tracks for guiding the movement of the punches. 5) A feeding mechanism for moving granulation from hopper into the dies Tablet Compression Machine: Tablet Compression Machine Die Filling and tablet ejection process: Die Filling and tablet ejection process Evaluation of Tablet: Evaluation of Tablet General Appearance Weight variation test Size and shape Content Uniformity test Unique Identification marking Disintegration test Organoleptic Properties Dissolution test Hardness Friability Tablet Coating: Tablet Coating To mask the taste of unpalatable drugs, protect the drug from deterioration due to light, oxygen or moisture, separate in compatible ingredients, control there lease of medicament in the gastrointestinal tract, and provide an elegant or distinctive finish to the tablet. Types of Coating: Pan Coating Fluid bed Coating Compression Coating Machine Pan Coating: Pan Coating Spray nozzle for tablet coating: Spray nozzle for tablet coating Fluidised Bed Coating: Fluidised Bed Coating Tablet Deffects: Tablet Deffects Capping Lamination/Laminating Chipping Cracking Sticking/Filming Picking Binding Mottling Double impression Slide 22: Capping : (Upper or lower segment of tablet separates horizontally) Large amount of fines in the granulation Too dry or very low moisture content (leading to loss of proper binding action). Not thoroughly dried granules Insufficient amount of binder or improper  binder. Insufficient or improper lubricant. Granular mass too cold to compress firm Poorly finished dies Deep concave punches or  beveled‐edge faces of punches. Lower punch remains below the  face of die during ejection. High turret speed. : LAMINATION: (Separation of tablets into two or more distinct horizontal layers ) Rapid relaxation of the peripheral regions of a tablet, on ejection from a die Rapid decompression. Use pre‐compression step.  CHIPPING : ( breaking of tablet edges while the tablet leaves the press) Sticking on punch faces Too dry granules Too much binding causes chipping at bottom Groove of die worn at compression point Barreled die (center of the die wider than ends) Edge of punch face turned inside/inward Concavity too deep to compress properly High degree of attrition associated with coating process Slide 24: Sticking : (Adherence of tablet material to die) Granules not dried properly Too little or improper lubrication Too much binder Too soft or weak granules Cracking (Small fine cracks observed on upper and lower surface of tablets) Large size of Granules Too dry granules Granulation condition too cold Tablet expansion during ejection due to entrapment of air Deep concavities in dies and punches Picking (Product sticking only within letters,logos,or designs on punch faces ) Low melting point substances may soften due to heat of compression Too warm granules when compression Too much amount of binder Dividing lie too deep Slide 25: Pressure applied is not enough Rough punch faces Binding (Sticking of tablet to the die and does not eject properly out of die ) Too moist granules Insufficient or improper lubricant Too coarse granules Too hard granules for the lubricant to be effective Poorly finished dies Rough dies due to abrasion or corrosion Undersized dies MOTTLING (unequal distribution of color on tablet) Colored drug used along with colorless or white colored excipients Dye migration to surface of granulation while drying Improper mixing of dye during “Direct Compression” Improper mixing of color binder solution Slide 26: Blistering (Detachment of film from the substrate forming a blister ) Effect of temperature on the strength, elasticity and  adhesion of the film Overheating during spraying coating solution  Cratering (Defect of film coating: - volcanic like craters appears exposing tablet surface ) Penetration of coating solution into the surface of tablet Inefficient drying Pitting (Pits occurs on the surface of tablet) Incontinous spreading of film Temperature of core is greater than melting point of material used in tablet Blooming (Polish of tablet show dull appearance) Prolong storage Surface roughness Slide 27: ORANGE PEEL (Coating texture that resembles orange peel surface) Shows “Orange peel” effect of the coating film Rapid Drying High Coating solution viscosity Slide 28: Some important facts India’s cost of production is nearly 33 per cent lower than that of the US Labour costs are 50–55 per cent cheaper than in Western countries. Cost of setting up a production plant in India is 40 per cent lower than in Western countries India has a skilled workforce as well as high managerial & technical competence in comparison to its peers in Asia India has the 2nd largest number of USFDA-approved manufacturing plants outside the US India has 2,633 FDA-approved drug products. India has over 546 USFDA-approved company sites, the highest number outside the US Economic prosperity would improve affordability for generic drugs in the market & improve per capita sales of pharmaceuticals in India

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