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Research & Development (R&D) - Formulation
Research & Development (R&D) - Formulation
Research & Development (R&D) - Formulation
Pre-formulation Development
A Reference Listed Drug (RLD) which is an FDA approved drug product can be
referred to by a generic drug manufacturer while filing an Abbreviated New Drug
Application (ANDA). It is useful to establish bioequivalence of the product with that
of an already approved one by determining the following details in drug development:
Product name
Active pharmaceutical ingredient (API)
Strength and dosage form
Packaging and pack size
Manufacturer
Manufacturing and expiry date
Physical properties - appearance, tablet weight, dimension, hardness,
disintegration time, friability, coating type and dissolution
Next, it will be followed by characterization of API, selecting the right excipients
based on its functions, where the percentage usage shall be compendial in Handbook
of Pharmaceutical Excipients/Drug Registration Guidance Documents (DRGD).
Lastly, compatibility study of API-excipient need to be determine as interaction
between API and excipients may affect the assay of API and causing presence of
undesired degradation products
Formulation development
Formulation trial batch can be conducted to optimize the formula and manufacturing
process. Stability studies allow evaluation of API stability under the influence of a
variety of environmental and data from these studies enable recommended
storage conditions, retest intervals and shelf lives to be established. Pilot batch
manufacturing involved at least least 1/10 of the commercial batch size. Meanwhile,
Review Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR)
helps to monitor manufacturing process. Lastly, for registering products, dossier
needs to be prepared involving all necessary related documents of product technical
dossier according to regulatory requirements such as following:
Pilot Batch Report
Product Development Report
Calculation of restricted excipients (menthol, saccharin sodium)
Drug Master File (DMF) of API.
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