A novel injection-molded capsular device for oral pulsatile delivery based on swellable/erodible polymers.
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.
Dipartimento di Scienze Farmaceutiche P. Pratesi, Università degli Studi di Milano, Via G. Colombo 71, 20133 Milan, Italy. andrea.gazzaniga@unimi.it
Andrea
A
Gazzaniga
Matteo
M
Cerea
Alberto
A
Cozzi
Anastasia
A
Foppoli
Alessandra
A
Maroni
Lucia
L
Zema
D000082:Acetaminophen / Q000008:administration & dosage* / Q000737:chemistry; D000284:Administration, Oral; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage* / Q000737:chemistry; D002214:Capsules; D002482:Cellulose / Q000031:analogs & derivatives / Q000737:chemistry; D003106:Colon / Q000187:drug effects*; D003692:Delayed-Action Preparations; D016503:Drug Delivery Systems; D005079:Excipients; D006358:Hot Temperature; D006801:Humans; D004364:Pharmaceutical Preparations; D020959:Polyethylene / Q000737:chemistry; D011092:Polyethylene Glycols / Q000737:chemistry; D011673:Pulsatile Flow; D013997:Time Factors
D018712:Analgesics, Non-Narcotic; D002214:Capsules; D003692:Delayed-Action Preparations; D005079:Excipients; D004364:Pharmaceutical Preparations; D000082:Acetaminophen; D011092:Polyethylene Glycols; D020959:Polyethylene; D002482:Cellulose; C008079:hydroxypropylcellulose
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