The feasibility of injection molding was explored in the preparation of a novel capsular device for oral pulsatile/delayed delivery based on swellable/erodible polymers. For this purpose, a mold intended to be coupled with a bench-top injection-molding press was designed. This was expected to enable the preparation of matching capsule cap and body items within a single manufacturing cycle and the selection of differing shell thicknesses (300, 600, and 900 μm). Hydroxypropylcellulose (Klucel(®) EF, LF, and GF) was employed as the release-controlling polymer in admixture with polyethylene glycol 1500 (10%, w/w) as the plasticizer. After preliminary trials aimed at the setup of operating conditions, Klucel(®) EF and LF capsule shells with satisfactory technological properties were manufactured. The performance of capsular devices filled with a tracer drug powder was studied by means of a modified USP31 disintegration apparatus. Typical in vitro delayed release patterns were thereby obtained, with lag time increasing as a function of the wall thickness. A good correlation was found between the latter parameter and t (10%), i.e., the time to 10% release, for both polymer grades employed. On the basis of the overall results, the investigated technique was proven suitable for the manufacturing of an innovative pulsatile release platform.
A novel injection-molded capsular device for oral pulsatile delivery based on swellable/erodible polymers / A. Gazzaniga, M. Cerea, A. Cozzi, A. Foppoli, A. Maroni, L. Zema. - In: AAPS PHARMSCITECH. - ISSN 1530-9932. - 12:1(2011 Mar), pp. 295-303.
|Titolo:||A novel injection-molded capsular device for oral pulsatile delivery based on swellable/erodible polymers|
GAZZANIGA, ANDREA (Primo)
CEREA, MATTEO (Secondo)
MARONI, ALESSANDRA (Penultimo)
ZEMA, LUCIA (Ultimo)
|Parole Chiave:||capsular device; hydroxypropylcellulose (HPC); injection molding; oral drug delivery; pulsatile/delayed release|
|Settore Scientifico Disciplinare:||Settore CHIM/09 - Farmaceutico Tecnologico Applicativo|
|Data di pubblicazione:||mar-2011|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1208/s12249-011-9581-6|
|Appare nelle tipologie:||01 - Articolo su periodico|