Finished Dosage Forms
Finished Dosage Formulation
A Finished Dosage Form is a finished drug product resulting from Finished Dosage Formulation (FDF), the various processes involved in production such as manufacturing, testing, and subsequent approval for consumption and delivery to the public.
Active Pharmaceutical Ingredients (API’s), responsible for the results the user gets after taking the dosage forms, are involved in the FDF along with inactive ingredients (excipients) which serve as a medium for the active ingredients to function.
FDF is a critical stage in the product lifecycle and can only be achieved if the manufacturing facility of a pharmaceutical company or Contract Manufacturing Organization is up to a high-end standard. This is a major reason why some companies are into out-licensing since they don’t have the standard manufacturing facility to produce the dosage forms.
Processes Involved in Finished Dosage Formulation Development
The processes involved here are quite complex. Analysis comes first involving the active pharmaceutical ingredients and excipients. A compatibility study is also done between them.
Next is the formulation development which includes the definition of quantitative and qualitative formulas, formulating the manufacturing method, and establishment of in-process controls.
The next process is the main manufacturing process, which then proceeds to quality control, clinical trials, stability studies and manufacturing regulations before the drug product is transferred to the client if it’s been conducted by a pharmaceutical contract manufacturing organization.
What are the Benefits of Outsourcing Finished Dosage Formulation Development?
Formulation development is an integral process for any commercial manufacturing pharma company and even for private purposes in the development of solid dosage forms. This is why outsourcing always comes in handy because the pharmaceutical contract manufacturing firms are usually more equipped with state-of-the-art manufacturing equipment.
They also ensure that the drug product meets the required industry benchmark using the right method development and standard clinical trial materials to ensure there are no loopholes.
Overall, outsourcing ensures that the dosage form is up to the best standard and is duly regulated.
Growth in Finished Dosage Formulations Market
The key factors that are driving trends in the finished dosage formulation market are:
• Access to cutting-edge technological resources in the global pharmaceutical industry.
• An increased need to outsource drug development and pharmaceutical contract manufacturing.
• The increasing contract manufacturing market share of the industry.
Laws and Regulations for the Manufacture of Finished Dosage Formulation
The US FDA’s Current Good Manufacturing Practice regulations require three successful full-scale batches of finished dosage formulation. These three validation batches are essential to ensure that process design and development studies are up to the required standard for active pharmaceutical ingredients, excipients, and drug production generally. GMP compliance is vital to acquire a license to manufacture finished dosage formulations like soft gelatin capsules.
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