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Colon specific CODES based Piroxicam tablet for colon targeting: statistical optimization, in vivo roentgenography and stability assessment.
- Source :
-
Pharmaceutical development and technology [Pharm Dev Technol] 2015 Mar; Vol. 20 (2), pp. 237-45. Date of Electronic Publication: 2013 Nov 25. - Publication Year :
- 2015
-
Abstract
- This study was aimed to statistically optimize CODES™ based Piroxicam (PXM) tablet for colon targeting. A 3(2) full factorial design was used for preparation of core tablet that was subsequently coated to get CODES™ based tablet. The experimental design of core tablets comprised of two independent variables: amount of lactulose and PEG 6000, each at three different levels and the dependent variable was %CDR at 12 h. The core tablets were evaluated for pharmacopoeial and non-pharmacopoeial test and coated with optimized levels of Eudragit E100 followed by HPMC K15 and finally with Eudragit S100. The in vitro drug release study of F1-F9 was carried out by change over media method (0.1 N HCl buffer, pH 1.2, phosphate buffer, pH 7.4 and phosphate buffer, pH 6.8 with enzyme β-galactosidase 120 IU) to select optimized formulation F9 that was subjected to in vivo roentgenography. Roentgenography study corroborated the in vitro performance, thus providing the proof of concept. The experimental design was validated by extra check point formulation and Diffuse Reflectance Spectroscopy revealed absence of any interaction between drug and formulation excipients. The shelf life of F9 was deduced as 12 months. Conclusively, colon targeted CODES™ technology based PXM tablets were successfully optimized and its potential of colon targeting was validated by roentgenography.
- Subjects :
- Animals
Antineoplastic Agents chemistry
Colon metabolism
Drug Design
Drug Liberation
Drug Stability
Drug Storage
Gastrointestinal Transit
Models, Statistical
Piroxicam chemistry
Rabbits
Radiography
Tablets
Antineoplastic Agents administration & dosage
Colon diagnostic imaging
Excipients chemistry
Lactulose chemistry
Piroxicam administration & dosage
Technology, Pharmaceutical methods
Technology, Pharmaceutical statistics & numerical data
Subjects
Details
- Language :
- English
- ISSN :
- 1097-9867
- Volume :
- 20
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Pharmaceutical development and technology
- Publication Type :
- Academic Journal
- Accession number :
- 24266719
- Full Text :
- https://doi.org/10.3109/10837450.2013.860549