DoE-Optimized Minitabs: Fabricating a Promising Modified-Release Sprinkle Formulation.

Abstract

Background: Dysphagia is a challenging medical condition that significantly affects individuals' swallowing function, quality of life, and overall well-being, especially in geriatric and pediatric populations. Sprinkle formulations are emerging as a broadly accepted solution to this challenge. However, such formulations are quite challenging to formulate as modified-release delivery systems. The present study aims to resolve this issue by formulating modified-release minitabs of the model drug etoricoxib as a sprinkle formulation.

Methods: A fabricated metal mold and punch system was used to manually manufacture minitabs with a diameter of 3.2 mm and a weight of approximately 22 mg. The formulation derived from trial batches was further optimized using a 3 × 2 complete factorial design, as implemented in Stat- Ease Design Expert 7.0 software (trial version). Independent factors HPMC K4M (X1) and K100M (X2) were optimized against dependent factors: Hardness (R1), Friability (R2), and Drug release at 2 hrs (R3), 4 hrs (R4), and 8 hrs (R5).

Result: The derived, optimized formulation, based on a desirability function, sustained drug release for up to 8 hours and met all the acceptance criteria. The final dosage form was designed as a hard gelatin capsule filled with approximately 22 minitabs, in the form of a sprinkle formulation, to be sprinkled over soft foods for administration.

Conclusion: As the formulation was designed using a model drug, further investigations with other drugs can also be done with relevant changes in the optimized formulation. In summary, it can also be utilized as a platform for developing modified-release sprinkle formulations of other drugs.