Dosage forms, customization

ABC Pharmaceutical Industries is located (provide postal address). ABC Pharmaceutical Industries manufactures sterile pharmaceutical dosage forms in strict compliance to the cGMP, United States FDA guidelines. ABC Pharmaceutical Industries is supplying its products to its customers around the world. 

The manufacturer and user should mutually agree upon the excipient specifications. The manufacturer must have the facility and process capability to consistently meet the mutually agreed upon specifications of the excipient(s). Subcontracting or significant changes to a supplier s audited process that could affect the physical, chemical, or functionality of the excipient in a final dosage form should be immediately communicated or pre-approved as mutually agreed upon between customer and supplier. 

How the product will be used by the patient or the customer—Here again our industry is so diverse that we must indicate that the limits calculated should take into account the nature of the customer. Is the customer another company that uses the product, which may be a chemical, to make another intermediate, or is the customer the patient who actually takes the product in the form of a finished pharmaceutical dosage form Is the product a sterile product and do we need to consider bacteria as a potential contaminant or is the product a nonsterile product in which bacterial contamination may be a lesser issue If the product is a finished pharmaceutical dosage form, will it be used intravenously, orally, ophthalmically, topically, rectally, vaginally, or by other means ... 

The last type is comprised of academic institutions that provide assistance with custom synthesis, dosage form development, pilot-scale production, and production of clinical supplies in order to obtain additional income to support their academic programs. They have no interest in, nor are they equipped for, commercial production. Companies seeking outsourcing should be aware that students and faculty could form part or all of the staff of their operations this may be a disadvantage when considering using this type of contract manufacturer. 

A customer study funded by CIMA was done to measure consumer/patient reactions to fast dissolve. The population size was 5000 and spanned across a diverse age group. Patients were given a conventional tablet and an ODT and asked various questions. A significant majority of the patients said they would or might prefer a fast dissolve dosage form over a regular tablet or liquid. Only 12% of the patients rejected fast dissolve tablets. Most of the patients also indicated that they would ask their doctor for a fast dissolve version and would purchase a fast dissolve if available. 

Dosage form is highly flexible in that the release rate from the tablet can be customized to deliver a drug specific absorption profile associated with optimized clinical benefit and tolerability. 

The Pharmaceutical Development group can play a leading role in determining the pharmaceutical requirements for a new product from key customers. Customers may want more specific packs or delivery systems, and different markets still have their own preferences for different dosage forms. 

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