FORMULATION DEVELOPMENT AND IN-VITRO EVALUATION OF MIDAZOLAM SOLID DISPERSIONS AND THEIR BUCCAL FLASH DISINTEGRATING FILMS

Authors

  • Koganti Phani Jithendra Department of Pharmaceutics, Nirmala College of Pharmacy, Atmakur, Guntur dist, Andhra Pradesh, India
  • M. Sudhir Department of Pharmaceutics, Nirmala College of Pharmacy, Atmakur, Guntur dist, Andhra Pradesh, India
  • A. Rajendra prasad Department of Pharmaceutics, Nirmala College of Pharmacy, Atmakur, Guntur dist, Andhra Pradesh, India

Abstract

The main objective of the present work is to prepare novel buccal flash disintegrating film inorder to by-pass the first pass metabolism, thus increasing its oral bioavailability. But the water solubility of the drug is poor, so inorder to increase its water solubility solid dispersions of midazolam was prepared using different carriers (Hydroxypropyl β-cyclodextrins, Poloxamer-188, PEG-4000, PEG-3350+Poloxamer-407) in the ratios of 1:3, 1:5. After the preparation of solid dispersions, the in vitro release study was performed in PH 6.8 Phosphate buffer for 1 hour. The effect of carrier concentration was studied. It was observed that the solid dispersion with Poloxamer-188 in a ratio of 1:5 by Co-grinding technique was successful in fast release of drug when compared to the pure drug. The optimized solid dispersion is further used to prepare flash disintegrating buccal films using different grades of HPMC. It was observed observed that the formulation F3 was successful in fast release of the drug from the prepared buccal flash-disintegrating films.The FTIR study revealed that there was no chemical interaction between drug and excipients.

 

Keywords: Midazolam, Solid-Dispersions, Anti-Convulsant, Hydroxypropyl β-cyclodextrins, Poloxamer-188, PEG-4000, PEG-3350+Poloxamer-407, HPMC E-15LV, HPMC E-5, buccal flash-disintegrating films.

References

Rongliu Text book of water insoluble drug formulations by page no.500-523.

Http://www.pharmainfo.net/reviews/current-trends-solid-dispersions-techniques-link for current trends in solid dispersions.

http://en.wikipedia.org/wiki/Midazolam

http://en.wikipedia.org/wiki/Epilepsy

Md. Sariful Islam Howlader, JayantaKishorChakrabarty,*KhandokarSadique Faisal, Md. RaihanSarkar, Mohammad Firuz Khan, Uttom Kumar-Enhancing dissolution profile of diazepam using hydrophilic polymers by solid dispersion technique International Current Pharmaceutical Journal 2012, 1(12): 423-430.

M.D. NehalSiddiqui, GarimaGarg and Pramod Kumar Sharma-A Short Review on “A Novel Approach in Oral Fast Dissolving Drug Delivery System and Their Patents” Advances in Biological Research 5 (6): 291-303, 2011.

Roul LK*, Manna NK , Parhi RN , Sahoo S and Suresh P-Dissolution rate enhancement of Alprazolam by Solid Dispersion Ind J Pharm Edu Res, Jan-Mar, 2012/ Vol 46/ Issue1.

AdinarayanaGorajana, AdhiyamanRajendran, NalamoluKoteswaraRao-preperation and in vitro evaluation of solid dispersions of nimodipine using peg 4000 and pvp k30 JPRHC April 2010 Volume 2 Issue 2.

D.akiladevi, p.shanmugapandiyan, preparation and evaluation of paracetamol by solid dispersion technique, international journal of pharmacy and pharmaceutical sciences, issn- 0975-1491, vol 3, issue 1, 2011..

Bhumika Sharma, Vikrant Saini, Arvind Sharma-Preparation, Characterization and In-Vitro Evaluation of Atorvastatin Calcium Solid Dispersions with Various Hydrophilic Polymers and Its FDT Formulation ISSN: 2230-7842 CPR 2(4), 2012, 620-630.

http://www.drugbank.ca/drugs/Midazolam

Dhagla R. Choudhary ,Vishnu A.Patel, Usmangani K. Chhalotiya, Harsha V. Patel, Aliasgar J. Kundawala -Development and Characterization of Pharmacokinetic Parameters of Fast-Dissolving Films Containing LevocetirizineSci Pharm. 2012; 80: 779–787.

K.p.r. Chowdary, veeraiahenturi, preparation and evaluation of starch citrate. International journal of pharma research and development, (2011); 2(12), 9-17.

Hand book of pharmaceutical excipients 6thedition page 210-214

LalitJejurkar* and K.K.Tapar-preparation and characterization of mesalamine solid dispersions by kneading method IJPSR (2011), Vol. 2, Issue 10.

Swati C. Jagdale; Ajay S. Bhadoriya, Aniruddha R. Chabukswar-Solubility Enhancement and Formulation of Mouth Dissolving Tablet of Clonazepam with Solid Dispersion Technology Rev Ciênc Farm BásicaApl., 2012;33(1):83-94.

Pratik kumar Joshi, Harsha Patel, Vishnu Patel, and RushiPanchal- Formulation development and evaluation of mouth dissolving film of domperidone J Pharm Bioallied Sci. 2012 March; 4(Suppl 1): S108–S109.

Mona Nagar*, Mayank Nagar and Vikram Chopra- Formulation and evaluation of mouth dissolving film of antipsychotic drug aripiprazole Der Pharmacia Lettre, 2012, 4 (4):1221-1227.

M Koland, VP Sandeep, and NR Charyulu -Fast Dissolving Sublingual Films of Ondansetron Hydrochloride: Effect of Additives on in vitro Drug Release and Mucosal Permeation J Young Pharm. 2010 Jul-Sep; 2(3): 216–222.

Downloads

Published

2016-01-21

Issue

Section

Original Research Article