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Challenges in Developing Low-Dose Formulations

The goal of formulation development is to design a quality product and its manufacturing process to deliver consistently the intended performance of the product. A good formulation must be manufacturable, chemically and physically stable throughout the manufacturing process and product shelf-life, and bioavailable upon administration. It also must meet many other quality standards and special requirements to ensure the efficacy and safety of the product. [Pg.31]

These issues are common to all low-dose chug products and independent of platform technologies used in manufacturing the products. Therefore, it is important to understand and evaluate the factors affecting these quality attributes during product development. [Pg.32]

1 Content Uniformity in Powder Blend and Finished Product [Pg.32]

According to 21CFR 211.110(a), pharmaceutical manufacturers are legally required to demonstrate the adequacy of mixing to ensure uniformity of in-process powder blends and finished dosage units. The uniformity of dose unit is usually a product specification for oral solid dosage forms and is tested to ensure it meets the compendial acceptance criteria. [Pg.32]

Traditional powder blend sampling and testing is first used to demonstrate the adequacy of the powder mix. A series of studies are performed on the blending process and homogeneous testing procedure as follows  [Pg.33]


CHALLENGES AND STRATEGIES IN FORMULATION DEVELOPMENT OF ORAL LOW-DOSE DRUG PRODUCTS... [Pg.24]

The formulation and process challenges encountered in the development of low-dose drug products using dry granulation have been thoroughly discussed. In addition,... [Pg.154]

To address the challenges in low-dose dmg product development, we recently initiated an excipient library approach, which follows the philosophy, an ounce of prevention is worth a pound of cure. The idea was to create a library of excipient-related information such as chromatographic background, stability, compatibility, and effect on dmg recovery and release. This library serves as a general tool for low-dose dmg development. Using the library, development teams are able to screen for the most appropriate excipients at the development planning/design phase on the basis of both formulation and analytical requirements. This approach aims to reduce analytical development difficulties where possible. [Pg.328]

Formulation and Analytical Development for Low-Dose Oral Drug Products focuses on the key topics involved in the challenges and strategies in analytical, formulation, and regulatory perspectives for development of low-dose dmg products. The book begins with eight chapters devoted to aspects of formulation and process... [Pg.475]


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Challenges in developing

Challenges in development

Formulation development

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