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Formulation and evaluation of floating tablet of H2-receptor antagonist.
Drug Dev Ind Pharm. 2015; 41(9):1499-511.DD

Abstract

CONTEXT

Conventional sustained dosage form of ranitidine hydrochloride (HCl) does not prevent frequent administration due to its degradation in colonic media and limited absorption in the upper part of GIT.

OBJECTIVES

Ranitidine HCl floating tablet was formulated with sublimation method to overcome the stated problem.

METHODS

Compatibility study for screening potential excipients was carried out using Fourier transform infrared spectroscopy (FT-IR) and differential scanning chromatography (DSC). Selected excipients were further evaluated for optimizing the formulation. Preliminary screening of binder, polymer and sublimating material was based on hardness and drug release, drug release with release kinetics and floating lag time with total floatation time, respectively. Selected excipients were subjected to 3(2) factorial design with polymer and sublimating material as independent factors. Matrix tablets were obtained by using 16/32" flat-faced beveled edges punches followed by sublimation.

RESULTS

FT-IR and DSC indicated no significant incompatibility with selected excipients. Klucel-LF, POLYOX WSR N 60 K and l-menthol were selected as binder, polymer and sublimating material, respectively, for factorial design batches after preliminary screening. From the factorial design batches, optimum concentration to release the drug within 12 h was found to be 420 mg of POLYOX and 40 mg of l-menthol. Stability studies indicated the formulation as stable.

CONCLUSION

Ranitidine HCl matrix floating tablets were formulated to release 90% of drug in stomach within 12 h. Hence, release of the drug could be sustained within narrow absorption site. Moreover, the dosage form was found to be floating within a fraction of second independent of the pH of media ensuring a robust formulation.

Authors+Show Affiliations

a Department of Pharmaceutics , Parul Institute of Pharmacy , Vadodara , Gujarat , India and.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25243639

Citation

Kesarla, Rajesh S., et al. "Formulation and Evaluation of Floating Tablet of H2-receptor Antagonist." Drug Development and Industrial Pharmacy, vol. 41, no. 9, 2015, pp. 1499-511.
Kesarla RS, Vora PA, Sridhar BK, et al. Formulation and evaluation of floating tablet of H2-receptor antagonist. Drug Dev Ind Pharm. 2015;41(9):1499-511.
Kesarla, R. S., Vora, P. A., Sridhar, B. K., Patel, G., & Omri, A. (2015). Formulation and evaluation of floating tablet of H2-receptor antagonist. Drug Development and Industrial Pharmacy, 41(9), 1499-511. https://doi.org/10.3109/03639045.2014.959969
Kesarla RS, et al. Formulation and Evaluation of Floating Tablet of H2-receptor Antagonist. Drug Dev Ind Pharm. 2015;41(9):1499-511. PubMed PMID: 25243639.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Formulation and evaluation of floating tablet of H2-receptor antagonist. AU - Kesarla,Rajesh S, AU - Vora,Pratik Ashwinbhai, AU - Sridhar,B K, AU - Patel,Gunvant, AU - Omri,Abdelwahab, Y1 - 2015/07/21/ PY - 2014/9/23/entrez PY - 2014/9/23/pubmed PY - 2016/6/2/medline KW - Gastro-retentive dosage form KW - hollow tablet KW - low-density approach KW - ranitidine hydrochloride KW - sublimation SP - 1499 EP - 511 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 41 IS - 9 N2 - CONTEXT: Conventional sustained dosage form of ranitidine hydrochloride (HCl) does not prevent frequent administration due to its degradation in colonic media and limited absorption in the upper part of GIT. OBJECTIVES: Ranitidine HCl floating tablet was formulated with sublimation method to overcome the stated problem. METHODS: Compatibility study for screening potential excipients was carried out using Fourier transform infrared spectroscopy (FT-IR) and differential scanning chromatography (DSC). Selected excipients were further evaluated for optimizing the formulation. Preliminary screening of binder, polymer and sublimating material was based on hardness and drug release, drug release with release kinetics and floating lag time with total floatation time, respectively. Selected excipients were subjected to 3(2) factorial design with polymer and sublimating material as independent factors. Matrix tablets were obtained by using 16/32" flat-faced beveled edges punches followed by sublimation. RESULTS: FT-IR and DSC indicated no significant incompatibility with selected excipients. Klucel-LF, POLYOX WSR N 60 K and l-menthol were selected as binder, polymer and sublimating material, respectively, for factorial design batches after preliminary screening. From the factorial design batches, optimum concentration to release the drug within 12 h was found to be 420 mg of POLYOX and 40 mg of l-menthol. Stability studies indicated the formulation as stable. CONCLUSION: Ranitidine HCl matrix floating tablets were formulated to release 90% of drug in stomach within 12 h. Hence, release of the drug could be sustained within narrow absorption site. Moreover, the dosage form was found to be floating within a fraction of second independent of the pH of media ensuring a robust formulation. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/25243639/Formulation_and_evaluation_of_floating_tablet_of_H2_receptor_antagonist_ L2 - https://www.tandfonline.com/doi/full/10.3109/03639045.2014.959969 DB - PRIME DP - Unbound Medicine ER -