APPLICATION OF SYNTHETIC AND NATURAL POLYMERS IN PREPARATION AND CHARACTERIZATION OF DOMPERIDONE FAST-DISSOLVING FILMS

  • SARIPILLI RAJESWARI Department of Pharmaceutics, Maharajah’s College of Pharmacy, Vizianagaram, Andhra Pradesh, India. http://orcid.org/0000-0003-1131-9132
  • PATIBANDLA SAMEERA Department of Pharmaceutics, Maharajah’s College of Pharmacy, Vizianagaram, Andhra Pradesh, India.
  • KONCHADA ALEKHYA Department of Pharmaceutics, Maharajah’s College of Pharmacy, Vizianagaram, Andhra Pradesh, India.
  • KURALLA HARI Department of Pharmaceutics, Maharajah’s College of Pharmacy, Vizianagaram, Andhra Pradesh, India.

Abstract

Objective: The present research work is mainly focused on solubility enhancement of domperidone which is a biopharmaceutical classification system Class II drug using natural and synthetic polymers.


Methods: The solubility was enhanced by the kneading method with the drug: polymer (1:0.5, 1:0.75, and 1:1) using β-cyclodextrin. The fast dissolving films (FDFs) of domperidone were prepared by incorporating the solid dispersion (SD) SDK3 by solvent casting method using hydroxypropyl methylcellulose K15 M (HPMC) and gellan gum in various concentrations for preparing FDFs. Various pre- and post-compression parameters, drug and excipients compatibility studies were evaluated by Fourier transform infrared (FTIR) spectroscopy, differential scanning calorimetry (DSC), and X-ray diffraction analysis (XRD).


Results: The maximum drug release of 98.86 % was achieved within 30 min for 1:1 ratio of solid dispersion using β-cyclodextrin, was optimized and taken for further development of FDFs. From the in vitro drug release studies films prepared with 10% w/w of HPMC K 15 (FH5) and 10% w/w of gellan gum (FG5) showed enhanced dissolution rate compared to other formulations. The formulation FHG with combination of polymers, namely, HPMC K 15 and gellan gum in 1:1 ratio showed drug release of 97.22% within 15 min only when compared with the optimized formulations. FTIR and DSC studies revealed that there were no interactions between drug and excipients. XRD studies revealed slight conversion of crystalline form to amorphous. The optimized formulation FHG found to be stable under accelerated stability studies.


Conclusions: The polymers in combination are a potential candidate for use in the formulation of FDF.

Keywords: Fast-dissolving film, Domperidone, Gellan gum, Hydroxypropyl methylcellulose, β-cyclodextrins, and Solid dispersion

Author Biography

SARIPILLI RAJESWARI, Department of Pharmaceutics, Maharajah’s College of Pharmacy, Vizianagaram, Andhra Pradesh, India.

Pharmaceutical Technology

References

1. Kunte S, Tandale P. Fast dissolving strips: A novel approach for the delivery of verapamil. J Pharm Bioallied Sci 2010;2:325-8.
2. Sarita R, Raju L, Vinay D, Virendra Y. Formulation and evaluation of domperidone fast dissolving film by using different polymers. Int J Pharma Res Health Sci 2014;2:374-8.
3. Khatoon N, Raghavendra P. Overview on fast dissolving oral films. Int J Chem Pharm Sci 2013;1:63-75.
4. Subhash V, Basanti G, Guru S, Madhusudhan R. Overview on fast dissolving films. Int J Pharm Pharm Sci 2010;2:29-33.
5. Vijaya K, Ravishanker D, Rohini P, Subbarao M. Formulation and in vitro evaluation of sumatriptan succinate oral thin films. Indo Am J Pharm Res 2013;3:3016-25.
6. Patel N, Pancholi S. An overview on sublingual route for systemic drug delivery. Int J Res Pharm Biomed Sci 2012;3:913-23.
7. Dey P, Ghosh A. Wafers: An innovative advancement of oro-dispersible films. Int J Appl Pharm 2016;8:1-7.
8. Aggarwal J, Singh G, Saini S, Rana A. Fast dissolving films: A novel approach to oral drug delivery. Int Res J Pharm 2011;2:69-74.
9. Arun A, Chandra A, Vijay S, Kamla P. Fast dissolving oral films: An innovative drug delivery system and dosage form. Int J Chem Tech Res 2010;2:576-83.
10. Bala R, Pawar P, Khanna S, Arora S. Orally dissolving strips: A new approach to oral drug delivery system. Int J Pharma Investig 2013;3:67-76.
11. Hari K, Rajeswari S, Murthy KV. Preparation and evaluation of drotaverine HCl oral disintegrating tablets using solid mixture technique. Asian J Pharm Clin Res 2018;11:289-97.
12. Available from: http://www.emedicinehealth.com/drug-motilium/article_em.htm. [Last accessed on 2016 Oct 05].
13. Joshi P, Patel H, Patel V, Panchal R. Formulation and evaluation of mouth dissolving film of domperidone. J Pharm Bioall Sci 2012;4:108-9.
14. Ghodkea D, Nakhat P, Yeole P, Naikwade N, Magdum S, Shah R. Preparation and characterization of domperidone inclusion complexes with cyclodextrin: Influence of preparation method. Int J Pharm Res 2009;8:145-51.
15. Essa E, Balata G. Preparation and characterization of domperidone solid dispersions. Pak J Pharm Sci 2012;25:783-91.
16. Bahim E, El-Faham T, Mohammed F, El-Eraky N. Enhancement of solubility and dissolution rate of domperidone by utilizing different techniques. Bull Pharm Sci Assiut Univ 2011;34:105-20.
17. Chowdary KP, Prakasarao KS, Amar A. A factorial study on the effects of cyclodextrins, poloxamer 407 and PVP on the solubility and dissolution rate of valsartan. Int J Pharm Pharm Sci 2012;4:285-7.
18. Chowdary KPR, Prakasarao KS. Formulation development of etoricoxib tablets employing HP ? cyclodextrin-poloxamer 407- PVP K30: A factorial study. Asian J Pharm Clin Res 2012;5:161-4.
19. Chowdary KP, Prakasarao KS. Individual and combined effects of cyclodextrins, poloxamer and PVP on the solubility and dissolution rate of BCS class II drugs. Asian J Chem 2011;23:4520-4.
20. Anwar D, Ashok P, Minal B, Nidhi S, Naresh G. Design and development of nicotiana tabacum film using factorial design. Int J Pharm Pharm Sci 2016;8:115-23.
21. Ghada EY, Haidy AA. Design and evaluation of fast dissolving oro-dispersible films of metoclopramide hydrochloride using 32 multifactorial designs. Int J Pharm Pharm Sci 2016;8:218-22.
22. Shah T, Amin A, Parikh J, Parikh R. Process optimization and characterization of poloxamer solid dispersions of a poorly water soluble drug. AAPS Pharm Sci Tech 2007;8:E18-24.
23. Pathan A, Gupta M, Jain N, Dubey A, Agarwal A. formulation and evaluation of fast dissolving oral film of promethazine hydrochloride using different surfactant. J Innov Pharm Biol Sci 2016;3:74-84.
24. Anil M, Desai R. Formulation, optimization and evaluation of mouth dissolving film of nifedipine by using design of experiment. Asian J Pharm Sci 2016;2:73-7.
25. Rajeshwar V. Formulation and evaluation of rapid dissolving films of pravastatin sodium. Int J Biomed Adv Res 2015;6:594-8.
26. Higuchi TJ. Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. Pharm Sci 1963;52:1145.
27. Ritger PL, Peppas NA. A simple equation for description of solute release II. Fickian and anomalous release from swellable devices. J Control Release 1987;5:37.
28. Mahajan A, Chhabra N, Aggarwal G. Formulation and characterization of fast dissolving buccal films: A review. Der Pharm Lett 2011;3:158-60.
29. Ravi S, Ramesh D. Formulation and evaluation of domperidone fast dissolving tablets using Plantago ovata mucilage. Int J Pharm Sci Res 2013;4:3489-93.
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SARIPILLI RAJESWARI, PATIBANDLA SAMEERA, KONCHADA ALEKHYA, and KURALLA HARI. “APPLICATION OF SYNTHETIC AND NATURAL POLYMERS IN PREPARATION AND CHARACTERIZATION OF DOMPERIDONE FAST-DISSOLVING FILMS”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 12, no. 10, Aug. 2019, pp. 169-76, https://innovareacademics.in/journals/index.php/ajpcr/article/view/34800.
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