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Formulation and development of orodispersible sustained release tablet of domperidone.
Drug Dev Ind Pharm. 2016; 42(6):906-15.DD

Abstract

Commercially available domperidone orodispersible tablets (ODT) are intended for immediate release of the drug, but none of them have been formulated for sustained action. The aim of the present research work was to develop and evaluate orodispersible sustained release tablet (ODT-SR) of domperidone, which has the convenience of ODT and benefits of controlled release product combined in one. The technology comprised of developing sustained release microspheres (MS) of domperidone, followed by direct compression of MS along with suitable excipients to yield ODT-SR which rapidly disperses within 30 seconds and yet the dispersed MS maintain their integrity to have a sustained drug release. The particle size of the MS was optimized to be less than 200 μm to avoid the grittiness in the mouth. The DSC thermograms of MS showed the absence of drug-polymer interaction within the microparticles, while SEM confirmed their spherical shape and porous nature. Angle of repose, compressibility and Hausner's ratio of the blend for compression showed good flowability and high percent compressibility. The optimized ODT-SR showed disintegration time of 21 seconds and matrix controlled drug release for 9 h. In-vivo pharmacokinetic studies in Wistar rats showed that the ODT-SR had a prolonged MRT of 11.16 h as compared 3.86 h of conventional tablet. The developed technology is easily scalable and holds potential for commercial exploitation.

Authors+Show Affiliations

a C.U. Shah College of Pharmacy, SNDT Women's University , Mumbai , Maharashta , India .b Department of Pharmaceutics & Drug Delivery , University of Mississippi , University , MS , USA , and.b Department of Pharmaceutics & Drug Delivery , University of Mississippi , University , MS , USA , and.a C.U. Shah College of Pharmacy, SNDT Women's University , Mumbai , Maharashta , India . c School of Pharmacy and Biomedical Sciences, University of Central Lancashire , Preston , UK.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26472165

Citation

Patil, Hemlata G., et al. "Formulation and Development of Orodispersible Sustained Release Tablet of Domperidone." Drug Development and Industrial Pharmacy, vol. 42, no. 6, 2016, pp. 906-15.
Patil HG, Tiwari RV, Repka MA, et al. Formulation and development of orodispersible sustained release tablet of domperidone. Drug Dev Ind Pharm. 2016;42(6):906-15.
Patil, H. G., Tiwari, R. V., Repka, M. A., & Singh, K. K. (2016). Formulation and development of orodispersible sustained release tablet of domperidone. Drug Development and Industrial Pharmacy, 42(6), 906-15. https://doi.org/10.3109/03639045.2015.1088864
Patil HG, et al. Formulation and Development of Orodispersible Sustained Release Tablet of Domperidone. Drug Dev Ind Pharm. 2016;42(6):906-15. PubMed PMID: 26472165.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Formulation and development of orodispersible sustained release tablet of domperidone. AU - Patil,Hemlata G, AU - Tiwari,Roshan V, AU - Repka,Michael A, AU - Singh,Kamalinder K, Y1 - 2015/10/16/ PY - 2015/10/17/entrez PY - 2015/10/17/pubmed PY - 2016/12/28/medline KW - Antiemetic KW - microspheres KW - orodispersible tablet KW - sustained release SP - 906 EP - 15 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 42 IS - 6 N2 - Commercially available domperidone orodispersible tablets (ODT) are intended for immediate release of the drug, but none of them have been formulated for sustained action. The aim of the present research work was to develop and evaluate orodispersible sustained release tablet (ODT-SR) of domperidone, which has the convenience of ODT and benefits of controlled release product combined in one. The technology comprised of developing sustained release microspheres (MS) of domperidone, followed by direct compression of MS along with suitable excipients to yield ODT-SR which rapidly disperses within 30 seconds and yet the dispersed MS maintain their integrity to have a sustained drug release. The particle size of the MS was optimized to be less than 200 μm to avoid the grittiness in the mouth. The DSC thermograms of MS showed the absence of drug-polymer interaction within the microparticles, while SEM confirmed their spherical shape and porous nature. Angle of repose, compressibility and Hausner's ratio of the blend for compression showed good flowability and high percent compressibility. The optimized ODT-SR showed disintegration time of 21 seconds and matrix controlled drug release for 9 h. In-vivo pharmacokinetic studies in Wistar rats showed that the ODT-SR had a prolonged MRT of 11.16 h as compared 3.86 h of conventional tablet. The developed technology is easily scalable and holds potential for commercial exploitation. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/26472165/Formulation_and_development_of_orodispersible_sustained_release_tablet_of_domperidone_ L2 - http://www.tandfonline.com/doi/full/10.3109/03639045.2015.1088864 DB - PRIME DP - Unbound Medicine ER -