Process analytical technologyCritical quality attributeSolid oral dosage formQuality by designPROCESS ANALYTICAL TECHNOLOGYNEAR-INFRARED SPECTROSCOPYCONTINUOUS DIRECT COMPRESSIONTWIN-SCREW GRANULATIONBackgroundContinuous manufacturing, a new process that applies the concept of time rather than batch size, is ...
Process for manufacturing a solid oral dosage form of a loperamide compound (preferably the hydrochloride salt of loperamide) by dissolving a loperamide compound in a short chain alcohol (preferably ethanol) prior to combining with a pharmaceutically acceptable carrier(s). The present invention also re...
The quality and performance of a solid oral dosage form depends on the choice of the solid phase, the formulation design, and the manufacturing process. The potential for process-induced solid phase transformations must be evaluated during design and development of formulations and manufacturing proces...
Sejima:Even though large molecule drug development is growing at a fast rate, small molecule oral solid dosage form manufacturing will continue to play a dominant role for new drug development. Some of the large molecules will eventually make it into oral solid dosage format. Gregory:Providers of...
these materials, which may include not only the drug substance but also excipients as well as in-process materials. In the following, several manufacturing processes will be discussed to demonstrate when the particle size specification needs to be established for...
INDUSTRIAL PROCESS VALIDATION OF TABLET DOSAGE FORM: A REVIEW The present article gives an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process. The principal objective of dosage form design is to achieve a predictab... V ...
At this point, the customer can start manufacturing their oral solid dosage products. The IVEN OSD Turnkey Project provides pharmaceutical companies with a complete solution, saving them the hassle of coordinating various aspects of facility set-up and ma...
Twin-screw granulation process insight is growing as researchers employ new analytical technologies and investigate new ways to use the equipment. Ensuring OSD Quality and Safety Felicity Thomas August 3rd 2023 Current good manufacturing practices for oral solid dosage forms protect the product from conta...
PDA TR60-2-2017 Annex 1 Oral Solid Dosage Semisolid Dosage Forms英文原版资料.pdf,Technical Report No. 60-2 Process Validation: A Lifecycle Approach Annex 1: Oral Solid Dosage/ Semisolid Dosage Forms Process Validation: A Lifecycle Approach — Annex 1: Or
<div p-id="p-0001">The present invention relates to a process for the production of an abuse-proofed solid dosage form containing at least one active ingredient with potential for abuse and a binder w