Wet granulation, dry granulation and direct blending are the three most common granulation processes for solid dosage form production in the pharmaceutical industry for decades. However, each of the three mentioned process has its drawbacks, among which, the requirement of post-granulation operations is one of the major weakness.
For a drug substance administered via oral route, it should possess adequately aqueous solubility before passes through the gastrointestinal tract to complete the absorption, and then enters the blood steams for the pharmacological actions. Hence the solubility of a drug substance is one of the most important physicochemical properties to determine the drug’s fate to be developed the drug product for clinical applications.
Oral solid dosage forms, mainly in the forms of tablets and capsules, still dominate the drug product market for their convenience to patients, not only for administration, but also safe and easy to compliance. In manufacturing of oral solid dosage forms, the flowability of active pharmaceutical ingredient (API), excipients used to formulate the API, and formulations play an important role, and should be assessed in the drug product development stage. Even in the simplest processing route, the final blends containing the drug substance and excipients should present appropriate flowability in order to be compressed into tablets or filled into capsule shells. Poor flowability can cause segregation and stratification, and bad feeding which will consequently result in some manufacturing issues such as weight variation and bad content uniformity.
