Oral formulations, which form the chief category of pharmaceutical dosage forms, tend to need more excipients than other preparations. As a result, trends in oral solid-dosage forms have a significant impact on excipient demand. Excipients play an important role in formulating a dosage form. These are the ingredients which along with active pharmaceutical ingredients make up the dosage forms. Excipients act as protective agents, bulking agents and can also be used to improve bioavailability of drugs in some instances. Excipient selection must be done on the basis of characteristics an excipient offers such as chemically stable, non-reactive, low equipment and process sensitive, Inert to human body, nontoxic, acceptable with regards to organoleptic characteristics, economical.
At present there are a wide range of options available for these products. Now a days, various techniques such as spray drying, hot-melt extrusion, lipid-based drug delivery, and multiparticulate systems are increasingly being used in both drug development and the manufacture of solid dosage forms. Also, pharmaceutical providers are taking a holistic approach that places the patient at the center of everything they do. According to a recent survey, swallowing conventional solid tablets have become an issue for more than 50% of the people. This provides novel prospects to the pharmaceutical companies to better meet consumer needs by making pharmaceuticals more user-friendly. Hence, quality by design (QbD) and process analytical technology (PAT) are becoming more mainstream and manufacturers are placing increasing emphasis on raw materials and process controls. Excipients are also majorly used at present in these process. Excipient manufacturers are implementing the concepts of QbD in their manufacturing processes to improve the quality and consistency of the excipients. Pharmaceutical manufacturers are using excipients to make solid dosage drugs for oral care applications. The main concern in choosing excipients in solid oral-dosage forms is its global acceptance. Though pharmaceutical excipients are not estimated to deliver any therapeutic effects, excipients frequently change the performance of the delivery system. So, in order to overcome low solubility and other formulative difficulties, the utilization of various polymeric excipients in solid oral dosage forms has become widespread in recent years. The polymeric excipients incorporated into these advanced solid drug products notably contribute to their unique action.
Furthermore, one of the key advances in excipients is the development of coprocessed products for solid-dosage forms. These products are a combination of two or more standard excipients, which speeds up the formulation development process. Excipient quality plays a vital role in assuring safety, quality and efficacy of dosage forms. Standardization of excipients usually assure the customers of uniform quality across pharmaceutical products, while manufactures are assured of standardized prices of these excipients.
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