NDLI: Development of Controlled-Release Matrix Tablet of Risperidone: Influence of Methocel®- and Ethocel®-Based Novel Polymeric Blend on In Vitro Drug Release and Bioavailability

Content Provider	Springer Nature Link
Author	Badshah, Amir Subhan, Fazal Rauf, Khalid Irfan Bukhari, Nadeem Shah, Kifayatullah Khan, Samiullah Ahmed, Zia Khan, Ihsanullah
Copyright Year	2011
Abstract	Controlled-release (CR) matrix tablet of 4 mg risperidone was developed using flow bound dry granulation–slugging method to improve its safety profile and compliance. Model formulations F1, F2, and F3, consisting of distinct blends of Methocel® K100 LV-CR and Ethocel® standard 7FP premium, were slugged. Each batch of granules (250–1,000 μm), obtained by crushing the slugs, was divided into three portions after lubrication and then compressed to 9-, 12-, and 15-kg hard tablets. In vitro drug release studies were carried out in 0.1 N HCl (pH 1.2) and phosphate buffer (pH 6.8) using a paddle dissolution apparatus run at 50 rpm. The CR test tablet, containing 30% Methocel® and 60% Ethocel® (F3) with 12-kg hardness, exhibited pH-independent zero-order release kinetics for 24 h. The drug release rate was inversely proportional to the content of Ethocel®, while the gel layer formed of Methocel® helped in maintaining the integrity of the matrix. Changes in the hardness of tablet did not affect the release kinetics. The tablets were reproducible and stable for 6 months at 40 ± 2°C/75 ± 5% relative humidity. Risperidone and its active metabolite, 9-hydroxyrisperidone, present in the pooled rabbit’s serum, were analyzed with HPLC-UV at λ $_{max}$ 280 nm. The CR test tablet exhibited bioequivalence to reference conventional tablet in addition to the significantly (p < 0.05) optimized peak concentration, C $_{max}$, and extended peak time, T $_{max}$, of the active moiety. There was a good association between drug absorption in vivo and drug release in vitro (R $^{2}$ = 0.7293). The successfully developed CR test tablet may be used for better therapeutic outcomes of risperidone.
Starting Page	525
Ending Page	533
Page Count	9
File Format	PDF
Journal	AAPS PharmSciTech
Volume Number	12
Issue Number	2
e-ISSN	15309932
Language	English
Publisher	Springer US
Publisher Date	2011-04-15
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Pharmacy Biochemistry Biotechnology Pharmacology/Toxicology
Content Type	Text
Resource Type	Article

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