Anil M.Pethe,Riddhi B.Desai

Shobhaben Pratapbhai Patel School of Pharmacy&Technology Management,SVKM’S NMIMS University,Vile Parle(West),Mumbai 400 056,India

Formulation,optimization&evaluation of mouth dissolving flm of nifedipine by using design of experiment

Anil M.Pethe*,Riddhi B.Desai

Shobhaben Pratapbhai Patel School of Pharmacy&Technology Management,SVKM’S NMIMS University,Vile Parle(West),Mumbai 400 056,India

A R T I C L E I N F O

Article history:

Available online 23 November 2015

Nifedipine

Mouth dissolving flms

DOE

The oral mucosa is vascularized,drugs can be absorbed directly and can enter the systemic circulation without frstpass metabolism[1].This advantage can be used in preparing products with increased oral bioavailability of molecules that undergo frst pass metabolism.Thus oral mucosa is an attractive site for drug delivery[2,3].The objective of this research work is to formulate mouth dissolving flm of nifedipine for enhanced bioavailability.nifedipine is used to treat hypertension and angina pectoris.

In the present investigation,an attempt was made to develop mouth dissolving flms of nifedipine to achieve fast disintegration and dissolution characteristics with improved bioavailability by oral route.The drug&excipients were characterized as per IP 2014.Drug and excipients studies were conducted using FTIR.Oral flms of nifedipine were formulated using HPMC E5,PVP polymer as a flm forming agent and PEG-400 as plasticizer.The solvent casting method was used for the preparation of flms.A central composite design using Design Expert Software was used to optimize and evaluate the main effects,interaction effects and quadratic effects of the formulation ingredients on the disintegration time&in vitro drug release.A 2-factor,2-level design was observed to be the most suitable and appropriate for exploring quadratic response surfaces and constructing second-order polynomial models.nifedipine oral flm was evaluated for folding endurance,thickness,weight variation test,surface pH,content uniformity,disintegration test,&in vitro dissolution.The stability studies of the flms were performed for optimized batch as per ICH guideline.

No drug–excipients interaction was observed.The characterization studies depict the purity of drug&all the excipients used in the formulation.The IR spectrum of mixture ofnifedipine with all other excipients does not show any changes which indicates its compatibility with other excipients.As per DOE 11 different formulation trials were carried out.The optimized batch showed a disintegration time of 30 seconds& maximum%drug release was within 60 seconds as shown in Fig.1.

Fig.1–Contour plot(a)and 3D surface plot(b).

From the results,it can be concluded that the fast dissolving oral flm of nifedipine showed fast disintegration dissolution of drugs in salivary pH.Thus the prepared fast dissolving flms of nifedipine could be a better alternative for achieving rapid oral bioavailability in angina pectoris.

Acknowledgements

The authors acknowledge the support received from Dr. R.S.Gaud,Dean SPPSPTM for providing all the facilities for this project&Dr.P.G.Shrotriya,Research Director SPP SPTM for his technical guidance.

R E F E R E N C E S

[1]Thakur N,Bansal M,Sharma N,et al.A novel approach of fast dissolving flms and their patients.Adv Bio Res 2013;2:50–58.

[2]Yogita P,Vishaka H,Amruta B.Polymers used for fast disintegrating oral flms:a review.J Pharm Sci Rev Res 2013;2(1):169–178.

[3]Vijaya K,Gavaskar S,Sharan G,et al.Overview on fast dissolving flms.Int J Pharm Pharm Sci 2010;2:29–35.

*E-mail address:anil.pethe@nmims.edu;anilpethe@gmail.com.

Peer review under responsibility of Shenyang Pharmaceutical University.

http://dx.doi.org/10.1016/j.ajps.2015.10.059

1818-0876/?2016 Production and hosting by Elsevier B.V.on behalf of Shenyang Pharmaceutical University.This is an open access article under the CC BY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/).