Forming, manufacturing process

There are many factors that can affect the stability of a pharmaceutical product. These include the stability of the active drug(s), interactions between active and inactive ingredients, the dosage form, manufacturing process, the container system, and environment for shipping, handling, and storage. 

A-6 Extended Release Solid Oral Dosage Forms Manufacturing—Processing... 

Optimize/scale-up commercial dosage form, manufacturing process and finalize control strategy... 

The production of effervescent tablets is first of all a conventional solid dosage form manufacturing process, which has to be taken into consideration, due to the special characteristics of the product and some unusual features. 

In all manufacturing processes, grafting is achieved by the free-radical copolymerization of styrene and acrylonitrile monomers in the presence of an elastomer. Ungrafted styrene—acrylonitrile copolymer is formed during graft polymerization and/or added afterward. 

Heterogeneous vapor-phase fluorination of a chlorocarbon or chlorohydrocarbon with HP over a supported metal catalyst is an alternative to the hquid phase process. Salts of chromium, nickel, cobalt or iron on an A1P. support are considered viable catalysts in pellet or fluidized powder form. This process can be used to manufacture CPC-11 and CPC-12, but is hampered by the formation of over-fluorinated by-products with Httle to no commercial value. The most effective appHcation for vapor-phase fluorination is where all the halogens are to be replaced by fluorine, as in manufacture of 3,3,3-trifluoropropene [677-21 ] (14) for use in polyfluorosiHcones. 

Hydrazine forms a high (120.5°C) boiling azeotrope with water that has a composition of 58.5 mol % (71.48 wt %) N2H4 at 102.6 kPa (1.02 atm) pressure. This comphcates the separation of hydrazine from water in the manufacturing process because it necessitates the removal of a large amount of water in order to approach the azeotropic composition. 

Mechanical Properties and Structural Performance. As a result of the manufacturing process, some cellular plastics have an elongated cell shape and thus exhibit anisotropy in mechanical, thermal, and expansion properties (35,36). Efforts are underway to develop manufacturing techniques that reduce such anisotropy and its effects. In general, higher strengths occur for the paraHel-to-rise direction than in the perpendicular-to-rise orientation. Properties of these materials show variabiUty due to specimen form and position in the bulk material and to uncertainty in the axes with respect to direction of foam rise. Expanded and molded bead products exhibit Httie anisotropy. 

The various preparation processes and technologies used in dmg product manufacture also can effect product safety, stabihty, and performance, eg, compression during tablet manufacture. The principal processes used in dosage form manufacture are as foUows (15). 

The dominant commercial form of elemental phosphoms is the a-white aHotrope. a-White phosphoms is often designated simply as because the soHd consists of tetrahedral P molecules. In its pure form, it is a white soHd that forms a clear Hquid when melted. However, the commercial product is generally somewhat yellow, both as a soHd and as a Hquid, owing to the presence of small amounts of a ted phosphoms aHotrope. Commercial white phosphoms may also be slightly gray in color because of incomplete separation of coke dusts and other impurities generated in the manufacturing process. 

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