ABSTRACT

Hard shell capsules made for preclinical trials (PCcaps) can be used in animals for oral dosing of formulations or drugs alone with or without excipients or incorporation of solvents. The advantages of PCcaps include assurance of delivering consistent dosage levels, avoidance of regurgitation and upper gastrointestinal tract (GIT) irritation, taste and odor masking, and ease of dosing. Miniaturization is a new concept in pharmaceutical technology of solid dosage forms that involves the use of smaller quantities of new chemical entities (NCEs). Xcelodose is particularly suited for oral and inhalation delivery. The goal of this pharmaceutical technology should be to produce safe and quality formulations that can be achieved by built-in robust science via design of experiment (DOE). For drugs that may be destroyed by acidic medium in the gastric region or may cause gastric irritation or nausea, or targeted delivery, especially to the colon, starch capsules have been coated for delayed release for these purposes.