Going green: Development of a sustainable lipid-based enteric coating formulation for low-dose aspirin multiparticulate systems.

There is a rising awareness of pharmaceutical industry of both patient-centric and sustainable product development. Manufacturing of multiparticulate systems (MPS) with functional coating via solvent-free hot melt coating (HMC) can fulfill both requirements. An innovative lipid-based formulation was developed with the composition of palmitic acid and Grindsted® citrem BC-FS (BC-FS) for enteric coating of acetylsalicylic acid (ASA).

Impact of polysorbate 65 on tripalmitin crystal growth and release stability of hot melt coated multiparticulate systems.

Hydrochlorothiazide (HCT) multiparticulate systems (MPS) were hot melt coated with the binary mixture of tripalmitin (PPP) and polysorbate 65 (PS 65) to gain an immediate release profile. Once, HCT MPS were produced with a constant ratio of PPP/PS 65 (90:10) at three different coating amounts (15, 25, and 60%) and once the PPP/PS 65 ratio was varied on 98:2 and 80:20, by keeping the coating amount at 60%. PS 65 induced the polymorphic transformation of PPP from the α-form to its most stable β-form right after the hot melt coating (HMC).

Impact of Surface Properties of Core Material on the Stability of Hot Melt-Coated Multiparticulate Systems.

Hot melt coating (HMC) of an active pharmaceutical ingredient (API) powder with lipid-based excipients is an innovative method for manufacturing patient-convenient dosage forms. However, drug release instability is still its main industrial challenge. The correlation between the unstable pharmaceutical product performance with the solid-state alteration of lipids is currently well-investigated.