Tags

Type your tag names separated by a space and hit enter

Chitosan and enteric polymer based once daily sustained release tablets of aceclofenac: in vitro and in vivo studies.
AAPS PharmSciTech. 2008; 9(2):651-9.AP

Abstract

The purpose of this study was to develop a once daily sustained release tablet of aceclofenac using chitosan and an enteric coating polymer (hydroxypropyl methylcellulose phthalate or cellulose acetate phthalate). Overall sustained release for 24 h was achieved by preparing a double-layer tablet in which the immediate release layer was formulated for a prompt release of the drug and the sustained release layer was designed to achieve a prolonged release of drug. The preformulation studies like IR spectroscopic and differential scanning calorimetry showed the absence of drug-excipient interactions. The tablets were found within the permissible limits for various physicochemical parameters. Scanning electron microscopy was used to visualize the surface morphology of the tablets and to confirm drug release mechanisms. Good equivalence in the drug release profile was observed when drug release pattern of the tablet containing chitosan and hydroxypropyl methylcellulose phthalate (M-7) was compared with that of marketed tablet. The optimized tablets were stable at accelerated storage conditions for 6 months with respect to drug content and physical appearance. The results of pharmacokinetic studies in human volunteers showed that the optimized tablet (M-7) exhibited no difference in the in vivo drug release in comparison with marketed tablet. No significant difference between the values of pharmacokinetic parameters of M-7 and marketed tablets was observed (p > 0.05; 95% confidence intervals). However the clinical studies in large scale and, long term and extensive stability studies at different conditions are required to confirm these results.

Links

PMC Free PDF
PMC Free Full Text

Authors+Show Affiliations

Mutalik S
Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, 576104 Karnataka, India. ssmutalik@yahoo.com
Manoj K
No affiliation info available
Reddy MS
No affiliation info available
Kushtagi P
No affiliation info available
Usha AN
No affiliation info available
Anju P
No affiliation info available
Ranjith AK
No affiliation info available
Udupa N
No affiliation info available

MeSH

Administration, OralAnti-Inflammatory Agents, Non-SteroidalCalorimetry, Differential ScanningCelluloseChemistry, PharmaceuticalChitosanCross-Over StudiesDelayed-Action PreparationsDiclofenacDouble-Blind MethodDrug Administration ScheduleDrug CarriersDrug CompoundingDrug StabilityHumansHydrogen-Ion ConcentrationMethylcelluloseMicroscopy, Electron, ScanningSolubilitySpectrophotometry, InfraredSurface PropertiesTablets, Enteric-CoatedTechnology, PharmaceuticalTherapeutic Equivalency

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

18500561

Citation

Mutalik, Srinivas, et al. "Chitosan and Enteric Polymer Based once Daily Sustained Release Tablets of Aceclofenac: in Vitro and in Vivo Studies." AAPS PharmSciTech, vol. 9, no. 2, 2008, pp. 651-9.
Mutalik S, Manoj K, Reddy MS, et al. Chitosan and enteric polymer based once daily sustained release tablets of aceclofenac: in vitro and in vivo studies. AAPS PharmSciTech. 2008;9(2):651-9.
Mutalik, S., Manoj, K., Reddy, M. S., Kushtagi, P., Usha, A. N., Anju, P., Ranjith, A. K., & Udupa, N. (2008). Chitosan and enteric polymer based once daily sustained release tablets of aceclofenac: in vitro and in vivo studies. AAPS PharmSciTech, 9(2), 651-9. https://doi.org/10.1208/s12249-008-9075-3
Mutalik S, et al. Chitosan and Enteric Polymer Based once Daily Sustained Release Tablets of Aceclofenac: in Vitro and in Vivo Studies. AAPS PharmSciTech. 2008;9(2):651-9. PubMed PMID: 18500561.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Chitosan and enteric polymer based once daily sustained release tablets of aceclofenac: in vitro and in vivo studies. AU - Mutalik,Srinivas, AU - Manoj,Krishnan, AU - Reddy,Meka Sreenivasa, AU - Kushtagi,Pralhad, AU - Usha,Achutha Nayak, AU - Anju,Parambil, AU - Ranjith,Averineni Kumar, AU - Udupa,Nayanabhirama, Y1 - 2008/05/24/ PY - 2007/07/19/received PY - 2008/02/21/accepted PY - 2008/5/27/pubmed PY - 2008/9/16/medline PY - 2008/5/27/entrez SP - 651 EP - 9 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 9 IS - 2 N2 - The purpose of this study was to develop a once daily sustained release tablet of aceclofenac using chitosan and an enteric coating polymer (hydroxypropyl methylcellulose phthalate or cellulose acetate phthalate). Overall sustained release for 24 h was achieved by preparing a double-layer tablet in which the immediate release layer was formulated for a prompt release of the drug and the sustained release layer was designed to achieve a prolonged release of drug. The preformulation studies like IR spectroscopic and differential scanning calorimetry showed the absence of drug-excipient interactions. The tablets were found within the permissible limits for various physicochemical parameters. Scanning electron microscopy was used to visualize the surface morphology of the tablets and to confirm drug release mechanisms. Good equivalence in the drug release profile was observed when drug release pattern of the tablet containing chitosan and hydroxypropyl methylcellulose phthalate (M-7) was compared with that of marketed tablet. The optimized tablets were stable at accelerated storage conditions for 6 months with respect to drug content and physical appearance. The results of pharmacokinetic studies in human volunteers showed that the optimized tablet (M-7) exhibited no difference in the in vivo drug release in comparison with marketed tablet. No significant difference between the values of pharmacokinetic parameters of M-7 and marketed tablets was observed (p > 0.05; 95% confidence intervals). However the clinical studies in large scale and, long term and extensive stability studies at different conditions are required to confirm these results. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/18500561/Chitosan_and_enteric_polymer_based_once_daily_sustained_release_tablets_of_aceclofenac:_in_vitro_and_in_vivo_studies_ L2 - https://dx.doi.org/10.1208/s12249-008-9075-3 DB - PRIME DP - Unbound Medicine ER -