English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Tools annual

Global: Zendy Free Plan

Global: Zendy Tools monthly

Global: Zendy Plus monthly

The objective of this study was to develop pH independent controlled release matrix tablets of Ondansetron HCl by using Multi component Complexation technique, Methocel K100M as release retarding materials and HP β-cyclodextrin was selected as release modulators. Ondansetron is weakly basic drug and their salts shows pH-dependent solubility that may show drug release problems at higher pH of small intestine. Incorporation of weakly basic drugs, exhibiting pH dependent solubility, into oral controlled release delivery systems shows pH dependent release profiles. In the present investigation, an attempt was made to pH-solubility dependence of drug and dissolution enhancement was attained by inclusion complex of Ondansetron with HPβ-cyclodextrin at 1:1 (drug: β-CD) molar ratio and then prepared complex hydroxyl propyl methyl cellulose controlled released matrix tablets. The in vitro drug release studies were carried out in pH1.2 buffer for 2 hrs and then in pH 6.8 phosphate buffer up to 24 hrs. The formulated matrix tablet F4 (without complexation) was very slow and drug is not released completely from matrix tablets in 6.8 pH phosphate buffer. The matrix tablets prepared using HP βcyclodextrin with PVP (F8) showed a superior dissolution rate and good dissolution profile that was comparable to without complexation of Ondansetron HCl. Dissolution results showed pH independent controlled and almost complete release behavior of Ondansetron HCl up to 24 hrs time period. The drug release mechanism of the HPMC matrix tablets was found to be quasi Fickian mechanism. These results suggested that the oral bioavailability of Ondansetron HCl was significantly improved by Multi component Complexation strategies. Key word: Ondansetron HCl, pH independent controlled drug delivery, Hydroxypropyl-βcyclodextrin, Multi component complexes. DOI: 10.5530/ijper.50.4.19 Correspondence: A. Anil Kumar, Department of Pharmaceutics, Vikas College of Pharmacy, Vissannapeta, Krishna District, A.P., India. PIN: 521 215, Phone: 91-9866529250 E-Mail: anilkumar.adi@ gmail.com INTRODUCTION In the antiemetic category, across a broad range of therapeutic indications,. Ondansetron hydrochloride is a serotonin sub type-3 (5-hydroxytryptamine-3) receptor antagonist. It is a widely used drug for the treatment of several therapeutic purposes like antiemetic especially it is used in the prevention of post operative nausea and vomiting and chemotherapy or radiation induced nausea and vomiting. The pharmacokinetic outline Submission Date : 05-08-2016 Revision Date : 20-09-2016 Accepted Date : 23-09-2016 of Ondansetron which has a half-life of about 3-6 hrs with a time to peak plasma approximately 2 hrs. The present marketed available oral dosage form of Ondansetron liquid dosage form and orally dissolving tablet are indicated for administration in multiple daily doses, potentially over a multiple days. There is still a need for sustained safeguard predominantly when patients pH independent controlled release delivery system 666 Indian Journal of Pharmaceutical Education and Research | Vol 50 | Issue 4 | Oct-Dec, 2016 are faced with extended or recurrent treatment during which they are at risk of CINV and PONV.1,2 The recommended oral dose regimen of Ondansetron hydrochloride is 8 mg, three times a day. The dose of Ondansetron HCl should be varying to 8-32 mg a day. The selection of dose regimen should be determined by the severity of the treatment. Ondansetron solubility exhibits high solubility in stomach at low pH (pH 1.2) and at higher pH (6.8 pH phosphate buffer), it exhibits poor solubility. Ondansetron HCl is weakly basic pH dependent soluble drug. The drug precipitation was found upon entry into the small intestine that may also affect the amount of drug obtainable for uptake throughout the intestinal mucosa.3,4 The availability of existing literature indicates that some of the techniques were developed in previous works, we have reported for pH-independent drug release. Out of that, one is gastro retentive drug delivery system in which the drug will float constantly for long period of time which is a question mark and also in-vitro/ in-vivo correlation is very poor. And another technique was developed pH modulating agents; this technique was somewhat better but the formulator was observed some manufacturing defects and prolonged drug release is very difficult. Then, in an effort to reach, the present investigation is aimed to develop a pH-independent control drug release dosage form of Ondansetron HCl for better pH independent dissolution properties as well as controlled release rate of Ondansetron. Hence, OND-HP-CD complexes have prepared and an optimal formulation was consequently designed by the combination of these complexes into HPMC-based hydrophilic Matrix tablet once daily dosage form.5-7 One potential method of optimizing the efficacy of drug activity is through the use of rationally designed carrier materials such as Hydroxypropyl beta cyclodextrin (HPßCD) encapsulation technology. A chemically modified HP--CD, became a more interesting option than ß-CD to achieve Complexation because of better physicochemical properties and enhanced inclusion behavior. Studies had proven that this CD derivative is able to increase drug oral bioavailability With HP-ßCD, an aqueous drug complex preparation is very simple, of all the CD derivatives accessible, HP-ßCD is the safest, as it does not permeate the membranes, enhance the dissolution, of poorly water-soluble pH dependent soluble drugs. A recent publication from Gould and Scott concludes that HP-ßCD is well tolerate in most species, particularly if dosed orally, and shows limited toxicity.8-10 Hence’ the present study was undertaken to evaluate, by means of Multi component complexes in association with high molecular weight Methocelk100M matrix tablets as strategies to improve Ondansetron HCl oral bioavailability and also to obtain a delayed therapeutic effect of the drug as compared with a conventional formulation. The use of HP-cyclodextrin (CD) Multi component complexation has been attempted to overcome such pH dependent solubility and dissolution drawbacks.11 MATERIALS AND METHODS Ondansetron was received as a gift sample from Pranami Drugs Pvt. Ltd., Gujarath . HP-bete-cyclodextrin and Methjocel k100M was purchased from Yarrow chem. Product Mumbai, Micro crystalline cellulose (Avicel PH 101), Sodium hydroxide, Magnesium Stearate, and Talc were purchased from ( S.D. Fine Chem Ltd., India), respectively.

indian journal of pharmaceutical education

Hydroxypropyl-β-Cyclodextrin (HBC) Multicomponent Complexation and pH independent controlled release delivery system to Improved Dissolution and oral Bioavailability of Ondansetron HCI