NDLI: Development of a Melting Tablet Containing Promethazine HCl Against Motion Sickness

Content Provider	Springer Nature Link
Author	Haware, Rahul V. Chaudhari, P. D. Parakh, S. R. Bauer Brandl, A.
Copyright Year	2008
Abstract	The purpose of this study was to design a ‘Traveller Friendly Drug Delivery System’ for PM-HCl. Conventional promethazine (PM-HCl) tablets are bitter, need to be taken 1 h before symptoms and water is also needed. Taste-masked granules were produced with Eudragit$^{®}$ E100 by extrusion, and analyzed with FTIR, DSC, and XRD. Tablets formulated from granules by direct compression using Ac-Di-Sol, Polyplasdone$^{®}$-XL, Primojel$^{®}$ and ion-exchanger Tulsion$^{®}$339 and evaluated for mass uniformity, friability, tensile strength, drug content uniformity, water absorption ratio, in-vitro and in-vivo disintegration time and in-vitro dissolution studies. The observed drug-polymer interactions and reduced crystallinity may be reasons for increased dissolution rates. The formulated tablets were disintegrated within 15 s. Tablets (25 mg PM-HCl) with Ac-Di-Sol (4%) showed complete release within 1 min, while marketed conventional tablets (Phenergan$^{®}$; Rhone-Poulec) release 25% during the same period. A preliminary stability studies for the prepared tablets carried at 30 ± 2°C/60 ± 5% RH, and 40 ± 2°C/75 ± 5%RH for 3 months showed no significant changes in the tablets quality at 30 ± 2°C/60 ± 5% RH. However, at 40 ± 2°C/75 ± 5%RH marked increase in in-vitro disintegration time, tensile strength and decrease in friability and water absorption ratio was found. The present studies indicate the abilities of Eudragit$^{®}$ E 100 for taste masking and improving the dissolution profile of PM-HCl after complexation. In addition, by employing cost effective direct compression method, fast-dissolving tablets of 400 mg total weight with an acceptable quality could be prepared.
Starting Page	1006
Ending Page	1015
Page Count	10
File Format	PDF
Journal	AAPS PharmSciTech
Volume Number	9
Issue Number	3
e-ISSN	15309932
Language	English
Publisher	Springer US
Publisher Date	2008-09-03
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Eudragit$^{®}$ E 100 Eudragit$^{®}$ RD 100 promethazine hydrochloride rapidly disintegrating tablet stability study superdisintegrants Pharmacy Biochemistry Biotechnology Pharmacology/Toxicology
Content Type	Text
Resource Type	Article

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
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9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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