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Pharmaceutical Technology's Solid Dosage and Excipient Special Issue examines the use of mixed and coprocessed excipients, excipient-selection strategies for optimal funtionality, API-excipient compatability, stability, and formulation development through quality by design.
>>> The ad close for this Special Issue issue is
April 2 <<<
>>> The material due date is April 14
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2010 Solid Dosage and Excipient Special Issue WILL EXAMINE:
Oral Solid Dosage ISPE Baseline Guide for New and Renovated Facilities:
The author discusses the revision to the ISPE Baseline Guide, originally published in February 1998, for new and renovated oral solid-dosage facilities. Aside from focusing on compliance with the current FDA cGMP regulatory expectations, where applicable, the guide also discusses the differences between the US, European, and Japanese practices. Some major changes to the auide as risk management and risk assessment, containment, process analytical technology, manufacturing execution systems, and nonGMP subjects such as HSE and controlled substances are included.
Controlled Release Matrix Tablets with Polymethacrylates:
Polymethacrylates have been used in pharmaceutical formulations for more than 50 years. Traditionally, they have mainly been chosen as film coatings. However, due to their excellent binding properties and their various functionalities they are able to work as matrix formers and to provide specific features to controlled release (CR) matrix tablets. Several CR matrix tablets formulation examples are given using anionic, cationic and neutral polymethacrylates. The development of bupropion HCl matrix tablets is described in detail. Data include formulation development, process optimization and three months ICH stability testing.
New Trends in Creating Colors for Immediate-Release Film Coatings:
The author examines previous methods used for color creation and selection of immediate-release film-coatings and discusses a new film-coating system made using an manufacturing process that provides formulation scientists the opportunity to create their own custom , film-coating colors. The article details the R&D tools, a color software program and an R&D dispenser, that can be used in conjunction with these new coating systems to optimize custom color creation..
A Technical Forum: Excipients and Solid Dosage Manufacturing in a QbD Paradigm: The manufacture of tablets and capsules has long been a mainstay in the pharmaceutical industry, but as the industry adopts a quality-by-design (QbD) paradigm for manufacturing, the bar for process understanding of a manufacturing process and the functionality of excipients in a formulation is raised. Leading scientists involved in formulation development and manufacturing share their perspectives on how QbD is and will transform solid-dosage development and manufacturing.
Flexible Approaches to Accommodate Excipient Variability Using Principles of Quality by Design:
Pharmaceutical formulations generally comprise the active pharmaceutical ingredient (API) and excipients, which are then combined using specific processing. Quality by Design (QbD) requires understanding of raw material variabilities and their impact on finished product quality. Hitherto, excipient supplier involvement in the formulation development process has been limited, with the supplier often being unaware of the application or functionality, and the user being unaware of supplier process capabilities. This has to change for QbD to succeed. Excipients are a potential source of product variability, and are generally less well characterized than the APIs. Thus, QbD has emphasized the role of excipients, the once so-called “inert” ingredients, and they are now properly recognized as enabling the API to be converted to a medicinal product that can be administered safely and efficaciously to the patient. Excipients are also now subject to increasing scrutiny from users, regulators, pharmacopoeias, and other groups such as IPEC, ISPE, ASTM and NIPTE.
Regulating the Global Excipient Industry:
A look at the new IPEC Federation, which combines IPEC Americas, IPEC Europe, IPEC Japan and IPEC China, and how the standard-setting body plans to secure the global supply-chain for excipients once and for all. |
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