Oral Solid Dosage Forms
Development of oral solid dosage forms (tablets and capsules) can comprise a range of different types of processing steps that can influence on the solid state properties of a chosen API and/or excipients. Vice versa, the micro- and macroscopical properties of the chosen API and excipients can influence on the processing properties. It is of vital importance to gain knowledge of both how the properties of the input material as well as on how various types of processing steps like sieving, milling, mixing, blending, dry/wet granulation, drying, compression, coating, encapsulation and packaging will affect the quality of the intended product. Adroit Science has long experience in identifying the critical quality attributes of the in-going raw materials as well as in developing the knowledge needed to optimize and establish the final process. We have been involved in placing a range of oral solid dosage forms on the market and have experience from all solid state related steps in the process, from early discovery and evaluation of pre-CD API candidates, performing salt- and polymorph screening and selection of optimum final form for development followed by early formulation development and consecutive formulation and process optimization and scale up, support in QbD activities and in stability assessment, compilation of solid state related text chapters in regulatory submissions and finally answering possible questions from regulatory authorities to gain final approval for market.