• DARSHIT RAM Noble Pharmacy College, Junagadh, 362001, Gujarat, India
  • HIMANSHU PANKHANIYA Noble Pharmacy College, Junagadh, 362001, Gujarat, India



Cisapride, HPMCK100M, Pregelatinize, HPMCK4M


Objective: Cisapride is a novel prokinetic agent is best candidate for GERD. Cisapride 20 mg can be given thrice in a day given along with Proton pump inhibitor. By developing the sustain release formulation of Cisapride, the frequency of both drug can be reduce to once only to obtain good therapeutic response.

Methods: Cisapride SR Tablets were prepared by direct compression technique with HPMC K4M and HPMC K100M polymers. Followed by various evaluation tests including in vitro disintegration and dissolution, the formulation was optimized by 32 full factorial designs with drug release kinetic analysis, compatibility studies (FTIR) and stability studies.

Results: Results of Preformulation studies of the Cisapride indicate that it has poor flow property and compressibility property. To improve the flow and compressibility property, it was beneficial to use the directly compressible grade components in the formulation of tablet. Results of DSC study shown that there is no change in drug’s melting peak after the preparation of tablet. Hydrophilic matrix of HPMC K4M and HPMC K100M in combination sustained the Cisapride release effectively for more than 12h. The result indicates that the combination of HPMCK4M and HPMCK100M can be successfully, On the basis of the preliminary trials in the present study a32 full factorial design was employed to study the effect of independent variables, i.e. concentration of HPMCK4M(X1) and concentration of HPMCK100M(X2)on dependent variables like% drug release Q2, Q6 and Q10. Drug release is also dependent on the size of matrix tablets so, size and surface area was kept constant. Factorial batches F018, F019, F020, and F021 give the f2 value 75-100. Factorial batch F019 gives the highest f2 value 86.04 and also all the hour’s drug release was within the specified limits.

Conclusion: The prepared formulation of Cisapride sustains release matrix tablet was stable and effective in treatment.


Download data is not yet available.


Zamir D. Gastroesophageal reflux. Eur J Intern Med 2005;16:391-401.

Bravo SA, MC Lamas, CJ Salomon. In vitro studies of diclofenac sodium controlled-release from biopolymeric hydrophilic matrices. J Pharm Pharm Sci 2002;5:213-9.

Karakkattu J, R Pr. Etiology for liver diseases in the pediatric population. Asian J Pharm Clin Res 2017;10:91-4.

Manzotti ME, Catalano HN, Serrano FA, Di Stilio G, Koch MF, Guyatt G. Prokinetic drug utility in the treatment of gastroesophageal reflux esophagitis: a systematic review of randomized controlled trials. Open Med 2007;1:e171.

Takeda M, Mizutani Y, Yamano M, Tsukamoto K, Suzuki T. Gastric emptying in diabetic gastroparetic dogs: effects of SK-951, a novel prokinetic agent. Pharmacology 2001;62:23-8.

Hongo M, Okuno Y. Diabetic gastropathy in patients with autonomic neuropathy. Diabetic Med 1993;10:79S-81S.

Lee T, J Robinson. In remington: the science and practice of pharmacy; Gennaro, Ed. Lippincott Williams and Wilkins: Baltimore 2000;2:903-29.

Wiseman LR, Faulds D. Cisapride. Drugs 1994;47:116-52.

Kibbe AH. Handbook of pharmaceutical excipients: Amer pharmacists assn; 2000.

Moore JW, Flanner HH. Mathematical comparison of dissolution profiles. Pharm Technol 1996;20:64-74.

Costa P, Lobo JMS. Modeling and comparison of dissolution profiles. Eur J Pharm Sci 2001;13:123-33.

Cooper J, Gunn C. Powder flow and compaction. Tutorial Pharmacy. New Delhi, CBS Publishers and Distributors, India; 1986;10:20-30.

Alhamdany AT, Abbas AK. Formulation and in vitro evaluation of amlodipine gastroretentive floating tablets using a combination of hydrophilic and hydrophobic polymers. Int J Appl Pharm 2018;10:119-25.

Kovvasu SP, Chowdary K. Formulation development and in vivo evaluation of pioglitazone inclusion complexes: a factorial study. Int J Appl Pharm 2018;10:49-5.

Jangde R, Singh D. Compatibility studies of quercetin with pharmaceutical excipients used in the development of novel formulation. Res J Pharm Technol 2014;7:1101.

Khan A, Agrawal S. Formulation and evaluation of lumefantrine capsule prepared by using liquisolid technique. Int J Curr Pharm Sci 2018;10:43.

Sankalia JM, Sankalia MG, Mashru RC. Drug release and swelling kinetics of directly compressed glipizide sustained-release matrices: establishment of level A IVIVC. J Controlled Release 2008;129:49-58.

Rodriquez M, Vila Jato JL, Torres D. Design of a new multi particulate system for potential site-specific and controlled drug delivery to the colonic region. J Controlled Release 1998;55:67-77.

Vaidya N, N Yak R, Benhar R, Narayanswamy VB. Design and evaluation of controlled release tablets of paroxetine hydrochloride. Int Res J Pharm 2013;4:84-62.

Gupta P, Gnanarajan G, Kothiyal P. Floating drug delivery system: a review. Int J Pharm Res Rev 2015;4:37-44.

Pawar HA, Dhavale R. Development and evaluation of gastroretentive floating tablets of an antidepressant drug by thermoplastic granulation technique. Beni-Suef University J Basic Appl Sci 2014;3:122-32.

Sah SK, Badola A, Mukhopadhyay S. Development and evaluation of tioconazole loaded emulgel. Int J Appl Pharm 2017;9:83-90.

Kumar KK, Sasikanth K, Sabareesh M, Dorababu N. Formulation and evaluation of diacerein cream. Asian J Pharm Clin Res 2011;4:93-8.

Kikwai L, Babu RJ, Prado R, Kolot A, Armstrong CA, Ansel JC, et al. In vitro and in vivo evaluation of topical formulations of spantide II. AAPS PharmSciTech 2005;6:565-72.

Husseini GA, Pitt WG. Micelles and nanoparticles for ultrasonic drug and gene delivery. Adv Drug Delivery Rev 2008;60:1137-52.

Golla U, Nalla BK, Talla R, Gajam PK, Voore SK. Formulation and in vitro evaluation of gastroretentive drug delivery system of ciprofloxacin hydrochloride. Der Pharm Sin 2011;2:33-9.

Pati N, Gupta V, Velivela S, Mayasa V. Comparative study of effect various types of polymers on the extended-release of tapentadol HCl. Int J Pharm Tech 2016;8:12762-75.

Biswas M, Gupta RN, Parhi R, Sethi KK, Sahoo SK. Formulation and in vitro evaluation of gastroretentive floating drug delivery system of ritonavir. Turkish J Pharm Sci 2013;10:69-86.

Manimaran V, Damodharan N. Development of fast-dissolving tablets of amlodipine besylate by solid dispersion technology using poloxamer 407 and poloxamer 188. Asian J Pharm Clin Res 2017;10:135-41.

Choudhari PK, Jain HK, Sharma P, Srivastava B. A novel co-processed directly compressible release-retarding polymer: in vitro, solid-state and in vivo evaluation. Future J Pharm Sci 2018;4:29-40.

Ereira MG, Arruda MAZ. Trends in pre-concentration procedures for metal determination using atomic spectrometry techniques. Microchim Acta 2003;141:115-31.

Maheswari PD, Rambhau D, Narasu ML. Microparticles-entrapped micelles: a novel delivery system to improve solubility and dissolution rate of poorly water-soluble valsartan. J Microencapsul 2013;30:805-16.

Amelia A, Vikram K. Design and evaluation of matrix-based controlled-release tablets of diclofenac sodium and chondriotin sulphate. Am Assoc Pharm Sci 2007;8:88-97.

Basak SC, Jayakumar Reddy BM, Lucas Mani KP. Formulation and release behaviour of sustained-release ambroxol hydrochloride HPMC matrix tablet. Indian J Pharm Sci 2006;6:594-7.

Bhalla HL, Handa AK. Development and evaluation of controlled release tablets of carbamazepine. Indian Drugs 1999;4:100-5.

Chien YW. Controlled and modulated-release drug delivery systems. In: Swarbrick J, Balyan JC. Encyclopedia of pharmaceutical technology. New York: Marcel Dekker; 1990;2:281-313.

Ghugarkar P, Swain K, Suggala V, Adsare P, Shaik P. Review on bilayer tablet technology. World J Pharm Res 2009;4:1434-52.

Rashmin N, Praful D. Formulation and evaluation of dual-component tablets of metoprolol tartrate. Int J Pharm Chem Sci 2012;1:514-22.

Banerjee ND, Singh SR. Formulation and evaluation of compression coated tablets of cefpodoxime proxetil. Int J Pharma Sci Res 2013;4:104.

Atul K, Ashok KT, Narendra KJ, Subheet J. Formulation and in vitro in vivo evaluation of extended-release matrix tablet of zidovudine: influence of the combination of hydrophilic and hydrophobic matrix formers. Am Assoc Pharm Sci 2006;7:1-10.



How to Cite

RAM, D., and H. PANKHANIYA. “FORMULATION, EVALUATION AND OPTIMIZATION OF SUSTAINED-RELEASE DRUG DELIVERY SYSTEM OF CISAPRIDE TABLET”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 13, no. 9, Sept. 2021, pp. 56-62, doi:10.22159/ijpps.2021v13i9.41799.



Original Article(s)