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Evaluation and enhancement of physical stability of semi-solid dispersions containing piroxicam into hard gelatin capsules.
Acta Pol Pharm. 2013 Sep-Oct; 70(5):883-97.AP

Abstract

The aim of the study was to investigate the physical stability of the semi-solid dispersions into the hard gelatine capsules prepared with Gelucire 44/14, Labrasol and different additives such as microcrystalline cellulose (MCC), mannitol and lactose (alpha-monohydrate) used for enhancing the stability of the formulations. The master dispersion prepared with only Gelucire 44/14 (20% w/w) and Labrasol (80% w/w) was stored in a refrigerator (5 +/- 3 degrees C), while the modified dispersions with the additives (2% w/w) were kept in a climatic chamber (25 +/- 2 degrees C / 60 +/- 5% RH) for 12 months. Dissolution tests of the semi-solid dispersions were performed in media with different pH's immediatly after preparation and after 3, 6 and 12 months of storage. FTIR and DSC studies were also carried out at the same time points. The ideal storage condition for the master dispersion was found to be at 5 degrees C. The addition of MCC, mannitol and lactose (alpha-monohydrate) to the original dispersion afforded a solidification effect on the formulation at room temperature and showed the same dissolution behavior (not less than 85% of piroxicam within 30 min in pH 1.2, 4.5 and 6.8; and water) with the master. The dispersion including lactose was stable at 25 degrees C for 12 months. However, the ideal period of storage for the modified dispersions including MCC and mannitol was 6 months at 25 degrees C. FTIR and DSC results both confirmed the amorphous state of piroxicam in all semi-solid dispersions under storage conditions for 12 months.

Authors+Show Affiliations

Department of Pharmaceutical Technology, School of Pharmacy, Ankara University, 06100-Tandoğan, Ankara, Turkey. akaratas@pharmacy.ankara.edu.trNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

24147368

Citation

Karataş, Ayşegül, and Serife Bekmezci. "Evaluation and Enhancement of Physical Stability of Semi-solid Dispersions Containing Piroxicam Into Hard Gelatin Capsules." Acta Poloniae Pharmaceutica, vol. 70, no. 5, 2013, pp. 883-97.
Karataş A, Bekmezci S. Evaluation and enhancement of physical stability of semi-solid dispersions containing piroxicam into hard gelatin capsules. Acta Pol Pharm. 2013;70(5):883-97.
Karataş, A., & Bekmezci, S. (2013). Evaluation and enhancement of physical stability of semi-solid dispersions containing piroxicam into hard gelatin capsules. Acta Poloniae Pharmaceutica, 70(5), 883-97.
Karataş A, Bekmezci S. Evaluation and Enhancement of Physical Stability of Semi-solid Dispersions Containing Piroxicam Into Hard Gelatin Capsules. Acta Pol Pharm. 2013 Sep-Oct;70(5):883-97. PubMed PMID: 24147368.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation and enhancement of physical stability of semi-solid dispersions containing piroxicam into hard gelatin capsules. AU - Karataş,Ayşegül, AU - Bekmezci,Serife, PY - 2013/10/24/entrez PY - 2013/10/24/pubmed PY - 2013/11/15/medline SP - 883 EP - 97 JF - Acta poloniae pharmaceutica JO - Acta Pol Pharm VL - 70 IS - 5 N2 - The aim of the study was to investigate the physical stability of the semi-solid dispersions into the hard gelatine capsules prepared with Gelucire 44/14, Labrasol and different additives such as microcrystalline cellulose (MCC), mannitol and lactose (alpha-monohydrate) used for enhancing the stability of the formulations. The master dispersion prepared with only Gelucire 44/14 (20% w/w) and Labrasol (80% w/w) was stored in a refrigerator (5 +/- 3 degrees C), while the modified dispersions with the additives (2% w/w) were kept in a climatic chamber (25 +/- 2 degrees C / 60 +/- 5% RH) for 12 months. Dissolution tests of the semi-solid dispersions were performed in media with different pH's immediatly after preparation and after 3, 6 and 12 months of storage. FTIR and DSC studies were also carried out at the same time points. The ideal storage condition for the master dispersion was found to be at 5 degrees C. The addition of MCC, mannitol and lactose (alpha-monohydrate) to the original dispersion afforded a solidification effect on the formulation at room temperature and showed the same dissolution behavior (not less than 85% of piroxicam within 30 min in pH 1.2, 4.5 and 6.8; and water) with the master. The dispersion including lactose was stable at 25 degrees C for 12 months. However, the ideal period of storage for the modified dispersions including MCC and mannitol was 6 months at 25 degrees C. FTIR and DSC results both confirmed the amorphous state of piroxicam in all semi-solid dispersions under storage conditions for 12 months. SN - 0001-6837 UR - https://www.unboundmedicine.com/medline/citation/24147368/Evaluation_and_enhancement_of_physical_stability_of_semi_solid_dispersions_containing_piroxicam_into_hard_gelatin_capsules_ L2 - http://www.ptfarm.pl/pub/File/Acta_Poloniae/2013/5/883.pdf DB - PRIME DP - Unbound Medicine ER -