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Premium member Presentation Transcript Hard and soft gelatin capsules: Hard and soft gelatin capsules Mrs. Chetana d. modi 1Hard Gelatin Capsules: Hard Gelatin Capsules contain 12 - 16 % moisture typically filled with dry solids powders granules pellets tablets also contain colorant preservativesManufacture: ManufactureHard Gelatin Capsules: Hard Gelatin Capsules Advantages tasteless and odorless swallowing is easy flexibility in formulating uniquely suitable for blinded clinical trials useful for extemporaneous compounding by pharmacist Disadvantages tend to be more expensive to produce than tablets not suitable for highly soluble saltsSoft gelatin capsules: Soft gelatin capsules The definition of soft gelatin capsules Soft gelatin capsules are made of gelatin , glycerin (or a polyhydric alcohol such as sorbitol) and water etc. to hermetically seal and encapsulate liquids, suspensions, pasty materials, dry powders and even preformed granules, pellets, tablets. They may be manufactured to be oblong, oval or round in shape. The advantages of soft gelatin capsules 1) pharmaceutically elegant 2) easily swallowed by the patient 5 Turn to 34 Turn to 35Soft Gelatin Capsules (Softgels): Soft Gelatin Capsules (Softgels) consist of a continuous gelatin shell surrounding a liquid core formed, filled, and sealed in one operation shells are softened by addition of glycerin or polyhydric alcohol (ex. sorbitol) oblong, spherical, elliptical in shapeSlide 7: 7 Turn to 33Soft Capsules: Soft Capsules ADVANTAGES may contain liquids, suspensions, pastes rapid release of contents useful for drugs prone to oxidation DISADVANTAGES have a greater tendency to adhere to each other more expensive increased possibility of interactions between drug and shellPreparation of soft gelatin capsules: 9 Preparation of soft gelatin capsules 1. The plate process 钢板模压法 (using a set of molds) The plates contain die pockets . 1) placing a warm sheet of gelatin on the bottom plate 2) pouring the liquid-containing medications 3) placing the second sheet of gelatin 4) putting the top plate of the mold into place 5) pressing the mold to form, fill, and seal the capsules simultaneously 6) removing and washing the capsule Today, this equipment can no longer be purchased.Preparation of soft gelatin capsules: 10 Preparation of soft gelatin capsules 2. The rotary die process( 旋转模压法 1933, R. P. Scherer ) more efficient and productive 1) Liquid gelatin is formed into two ribbons 2) The two ribbons are brought together 3) Metered fill material is injected between the ribbons 4) These pockets of fill-containing gelatin are sealedSlide 11: 11Slide 12: 12 Rotary die soft capsule machine The dies for production of soft capsulePreparation of soft gelatin capsules: 13 Preparation of soft gelatin capsules 3. The reciprocating die process ( 往复模压法 1949, Norton company ) is similar to the rotary process in that ribbons of gelatin are formed and used to encapsulate the fill, but it differs in the actual encapsulating process. 1) A set of vertical dies continually open and close to form rows of pockets in the gelatin ribbons. 2) These pockets are filled with the medication and are sealed, shaped, and cut out of the film. 3) The capsules fall into refrigerated tanks which prevent the capsules from adhering to one another.Preparation of soft gelatin capsules: 14 Preparation of soft gelatin capsules 4. The Accogel machine ( 1949, Cyanamid comcany ) This equipment is unique in that it is the only equipment that accurately fills powdered dry solids. 5. Dripping method( 滴制法 )The nature of soft gelatin capsule shell: 15 The nature of soft gelatin capsule shell 1) The gelatin is pharmacopoeial grade with additional specifications required by the capsule manufacturer. a) Bloom strength : b) viscosity : Generally, 25 to 45 millipoise is acceptable. c) iron : ≤15ppmThe nature of soft gelatin capsule shell: 16 The nature of soft gelatin capsule shell 2) Plasticizers glycerin or sorbitol or combinations of these The ratio by weight of dry plasticizer to dry gelatin determines the “hardness” of the gelatin shell. 0.4/1 hard 0.6/1 medium 0.8/1 soft The ratio by weight of water to dry gelatin can vary from 0.7-1.3 to 1.0. 3) The color of the gelatin shellThe fill material of soft gelatin capsules: 17 The fill material of soft gelatin capsules 1) liquids a) water-immiscible volatile and nonvolatile liquids b) water-miscible, nonvolatile liquids c) water-miscible and relatively nonvolatile liquids e.g. propylene glycol , isopropyl alcohol d) Liquids that can easily migrate through the capsule shell cannot be encapsulated into soft gelatin capsules 2) solids (solutions, suspensions, pasty mass, dry powders, granules, pellets, or small tablets.)Compendial requirements for capsules: 18 Compendial requirements for capsules The requirements for added substances 1) are harmless in the quantities used 2) do not exceed the maximum amounts required to provide their intended effect 3) do not impair the product’s bioavailability, therapeutic efficacy or safety 4) do not interfere with requisite compendial assays and testsThe container and preservation condition described in USP: 19 The container and preservation condition described in USP containers 1) light resistant container( 避光 ): 2) well-closed container( 密闭 ): 3) tight container( 密封 ): 4) Hermetic Container ( 熔封或严封 ): Preservation conditions 1) Freezer: -25 ~ -10 ℃; 2) Cold: <8 ℃; 3) Cool: 8 ~ 15 ℃; 4) Room Temperature: The temperature prevailing in a working area. 5) Controlled Room Temperature: 20 ~ 25 ℃; 6) Warm: 30 ~ 40 ℃; 7) Excessive Heat: >40 ℃; 8) Protection from Freezing: (breakage of the container, loss of strength or potency, destructive alteration of its characteristics)Compendial requirements for capsules: 20 Compendial requirements for capsules Disintegration test for capsules 1) Method The capsules are placed in the basket-rack assembly, which is repeatedly immersed 30 times per minute into a thermostatically controlled fluid at 37 ℃ and observed over the time described in the individual monograph. 2) To fully satisfy the test, the capsules disintegrate completely into a soft mass having no palpably firm core , and only some fragments of the gelatin shell.Compendial requirements for capsules: 21 Compendial requirements for capsules Dissolution test for capsules 1) The apparatus, dissolution media and test is the same as that for uncoated and plain coated tablets. 2) Generally, when a dissolution test is applied to an existing capsule product, the disintegration test is unnecessary.Compendial requirements for capsules: 22 Compendial requirements for capsules Weight variation and content uniformity show the uniformity of dosage units. Weight variation W capsule – W emptied shell = W content 10 capsules labeled amount or average amount, ±10% 1) For hard capsules #1: W capsule should match W emptied shell . 2) For soft capsules #1: evaporating the washing solvent over 30 mins #2: avoid uptake or loss of moisture Content uniformity The amount of active ingredient should be within the range of 85% to 115% of the label amount for 9 of 10 capsules, with no unit outside the range of 70% to 125% of label amount.Compendial requirements for capsules: 23 Compendial requirements for capsules Other requirements: 1) content labeling: the quantity of each active ingredient 2) stability testing method: long-term stability testing, accelerated stability test aim: storage condition, shelf life 3) moisture permeation test: unit dose containerInspecting, counting, packaging, and storing capsules: 24 Inspecting, counting, packaging, and storing capsules 1) Inspecting visual or electronic inspection → uniform in appearance 2) Counting a) counting tray; b) counting and filling machines 3) Packaging unit dose and strip packaging (sanitary, identifiable, safe) 4) Storing in tightly capped container in a cool, dry placeThank you: Thank you You do not have the permission to view this presentation. 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