Difficulties in Developing Fixed Dose Combinations: A Survey of Pharmaceutical Companies

D. Sreedhar, Manthan D Janodia, Virendra S Ligade, Ajay G Pise, Pradeep M Muragundi And N. Udupa*

Introduction New drug discovery and development is a complex, lengthy, expensive and high-risk effort. It requires sound coordination of a wide range of specialized areas and infrastructure complying with prescribed regulations. A large scale company may be able to take up the challenging task of developing a new molecule where as the small to medium scale firms cannot afford to venture in to a high risk business of drug discovery. However in India, even large scale manufacturing firms are finding it difficult to endeavor in drug discovery and development. As a result many pharmaceutical companies are opting for various other business models, one of which is reformulating drugs to fixed dose combinations. The idea of reformulating the drugs, which were otherwise available as single solid dosage forms, came into the minds of the pharmaceutical firms for various reasons. Reformulating drugs, proven to be safe and effective into fixed dose combination (FDC) products, now represents an essential strategy for drug companies both large scale and small and medium scale to balance their product portfolios and maximize commercial returns. Pharmaceutical companies are building commercial markets at domicile by developing FDCs that offer clinical benefit and/or reduced risk while also improving patient compliance and extending the life cycle of established therapies.1 However, it is not been an easy task to venture into business of manufacturing fixed dose combinations either. Pharmaceutical companies are expected to conduct a thorough market research starting from, which diseases to target to the issues associated with regulatory approval before venturing into FDCs business.
Diseases and Conditions
Fixed dose combinations are especially useful in the treatment of certain diseases like human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), malaria and tuberculosis which usually require more than one drug. There are certain other conditions and diseases like cancer, cardiovascular diseases, diabetes, neuropsychiatry and pain, which recently gained attention of pharmaceutical manufacturers. There are quite a few companies abroad and many companies in India that manufacture fixed dose combinations currently.
Issues related to development of Fixed Dose Combinations
There are lots of issues which need to be addressed while developing fixed dose combinations (Table 1), a few were dealt in some reviews and many have to be assessed.2, 3 Issues related to cost effectiveness, patient compliance, physician compliance, rationale, regulatory safety has been well covered.2 As a part of pre-formulation development, it should be demonstrated that the individual ingredients are compatible with each other. Moreover, excipients and other materials used in the final dosage form should also be inert with the active components.4 There are many more issues like analytical, compatibility, dosage determination, formulation development and stability that need to be critically accessed. Regulatory related issues are of utmost importance for getting approval from a regulatory authority. It is mandatory to provide evidence related to efficacy, quality and safety of the proposed FDC, regardless of individual components efficacy, quality and safety proven previously. There are a few guidelines in place to guide the pharmaceutical firms involved in manufacturing fixed dose combinations.5.



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