Evaluation of the Physical-chemical Characteristics and Biopharmaceutical Performance of Dilu-Cap: A Complete Line of Excipients for Hard-shell Capsules.

The development of an efficient formulation for hardshell capsules needs to consider pharmaceutical and biopharmaceutical aspects to assist in the careful selection of excipients, which are essential ingredients for the formulation's good performance. They ensure correct bioavailability, solubility, stability, dose accuracy (weight variation and content uniformity), and organoleptic characteristics. Given this, DiluCap was developed as a line of excipients so that the pharmacist can compound every capsule formulation with ease and trust in its final characteristics. The line is composed of six excipients: 1) Dilucap SLD, for soluble active pharmaceutical ingredients Class I and III from the Biopharmaceutical Classification System - it promotes disintegration without a negative impact on dissolution; 2) Dilucap PSD, for poorly soluble active pharmaceutical ingredients Class II and IV - it favors the disintegration and dissolution of the active pharmaceutical ingredients; 3) Dilucap SR, for active pharmaceutical ingredients requiring modified/ slow release - it reduces the disintegration and release rate of the active pharmaceutical ingredients, promoting its slow release, and, also, prevents plasma peaks responsible for adverse effects; 4) DiluCap Hygro, for hygroscopic or deliquescent active pharmaceutical ingredients - it reduces hygroscopicity, deliquescence, and eutectic mixture formation; 5) DiluCap Antioxi, for active pharmaceutical ingredients susceptible to oxidation - it provides chemical stabilization due to antioxidant ingredients and reduces water activity and chemical degradation; 6) DiluCap OD, for orodispersible active pharmaceutical ingredients that can be compounded as sprinkle capsules or sublingual capsules - it favors transmucosal permeation. The testing conducted for the DiluCap line of excipients showed that all products have suitable flow properties (angle of repose and Carr's compressibility index), hygroscopicity, biopharmaceutical performance (dissolution profiles), and stability. This corroborates the allegations that DiluCap provides a science based line of excipients to the compounding pharmacies with proven functionality that saves time (reduces the preprocessing and the number of items in stock) and guarantees efficacy and safety of hard-shell oral capsules formulations.