title: Centrifugal air-assisted melt agglomeration for fast-release "granulet" design.
abstract: Conventional melt pelletization and granulation processes produce round and dense, and irregularly shaped but porous agglomerates respectively. This study aimed to design centrifugal air-assisted melt agglomeration technology for manufacture of spherical and yet porous "granulets" for ease of downstream manufacturing and enhancing drug release. A bladeless agglomerator, which utilized shear-free air stream to mass the powder mixture of lactose filler, polyethylene glycol binder and poorly water-soluble tolbutamide drug into "granulets", was developed. The inclination angle and number of vane, air-impermeable surface area of air guide, processing temperature, binder content and molecular weight were investigated with reference to "granulet" size, shape, texture and drug release properties. Unlike fluid-bed melt agglomeration with vertical processing air flow, the air stream in the present technology moved centrifugally to roll the processing mass into spherical but porous "granulets" with a drug release propensity higher than physical powder mixture, unprocessed drug and dense pellets prepared using high shear mixer. The fast-release attribute of "granulets" was ascribed to porous matrix formed with a high level of polyethylene glycol as solubilizer. The agglomeration and drug release outcomes of centrifugal air-assisted technology are unmet by the existing high shear and fluid-bed melt agglomeration techniques.
authors.affiliation: Non-Destructive Biomedical and Pharmaceutical Research Centre, Universiti Teknologi MARA, 42300 Puncak Alam, Selangor, Malaysia. wongtinwui@salam.uitm.edu.my
authors.forename: Tin Wui
authors.initials: TW
authors.lastname: Wong
authors.forename: Nafisah
authors.initials: N
authors.lastname: Musa
mesh_terms: D000388:Air; D002498:Centrifugation / Q000295:instrumentation; D002626:Chemistry, Pharmaceutical; D004867:Equipment Design; D005079:Excipients / Q000737:chemistry*; D007004:Hypoglycemic Agents / Q000737:chemistry*; D007700:Kinetics; D007785:Lactose / Q000737:chemistry; D008970:Molecular Weight; D010316:Particle Size; D011092:Polyethylene Glycols / Q000737:chemistry; D016062:Porosity; D011208:Powders; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods*; D014044:Tolbutamide / Q000737:chemistry*
chemical_list: D005079:Excipients; D007004:Hypoglycemic Agents; D011208:Powders; D011092:Polyethylene Glycols; D014044:Tolbutamide; D007785:Lactose