By Sarfaraz K. Niazi
Pharmaceutical formulations stay as a lot an artwork at the present time as they've got developed into complicated technological know-how. With exponential progress of well-known formulations, the necessity for prepared formulations has elevated. basically a cookbook for making medicinal drugs, the six-volume instruction manual comprises the recipes and procedure steps for over 2000 medications, together with a couple of biotechnology medicinal drugs. this primary quantity covers pills, either lined and uncoated and oral powders. the writer has painstakingly assembled this ebook from FDA New Drug purposes, patent purposes and the BASF e-book of typical formulations, all supplemented via his 30-plus years of expertise in pharmaceutical formulations
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Pharmaceutical formulations stay as a lot an paintings this present day as they've got advanced into advanced technology. With exponential progress of primary formulations, the necessity for prepared formulations has elevated. basically a cookbook for making medications, the six-volume guide includes the recipes and technique steps for over 2000 medicinal drugs, together with a few biotechnology medications.
Additional resources for Handbook of Pharmaceutical Manufacturing Formulations: Compressed Solid Products (Volume 1 of 6)
The generic manufacturer faces a serious problem when procuring supplies of APIs coming off patent. Whereas Title 35 USC, Section 112, Paragraph 1 for patentability of invention requires that the inventor fully disclose the invention, the fact is that “full disclosure” does not necessarily mean disclosing steps that do not appear material in the production of the raw material. For example, it is routine practice (though questionable) for inventors of new chemical entities not to describe every step needed to remove impurities, to obtain the correct crystal structure (of a polymorph), or to obtain the correct particle size in the manufacturing process.
If the metabolite contributes meaningfully to safety and efficacy, the metabolite and the parent drug should be measured. When the relative activity of the metabolite is low and does not contribute meaningfully to safety and efficacy, it does not need to be measured. The parent drug measured in these BE studies should be analyzed using a confidence interval approach. The metabolite data can be used to provide supportive evidence of comparable therapeutic outcome. Enantiomers vs. Racemates For BA studies, the measurement of individual enantiomers may be important.
B. Tablets — Lower Strength For modified-release tablets, when the drug product is in the same dosage form but in a different strength, is proportionally similar in its active and inactive ingredients, and has the same drug release mechanism, an in vivo BE determination of one or more lower strengths can be waived based on dissolution profile comparisons, with an in vivo study only on the highest strength. 8). The dissolution profile should be generated on the test and reference products of all strengths.
Handbook of Pharmaceutical Manufacturing Formulations: Compressed Solid Products (Volume 1 of 6) by Sarfaraz K. Niazi