Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Formulation and characterization of norethisterone transdermal patch as an alternative route to oral administration

Ümit Gönüllü , Dilek Şaki

Department of Pharmaceutical Technology, Faculty of Pharmacy, Istanbul University, Beyazit, Istanbul 34116, Turkey;

For correspondence:- Ümit Gönüllü Email: ecz_gonullu@yahoo.com Tel:+902124400000

Accepted: 22 November 2017 Published: 29 December 2017

Citation: Gönüllü &, Şaki D. Formulation and characterization of norethisterone transdermal patch as an alternative route to oral administration. Trop J Pharm Res 2017; 16(12):2785-2792 doi: 10.4314/tjpr.v16i12.1

© 2017 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: To design a transdermal norethisterone (NE) patch for controlled drug release

Methods: Polymers, viz, sodium salt of carboxymethyl cellulose (CMCNa) and hydroxyethyl cellulose (HEC), as well as a plasticizer (propylene glycole, PG) were used at various ratios to prepare NE films. The drug was dispersed in water and mixed with the polymer gel/plasticizer mixture prior to film casting. Weight variation, thickness, tensile strength, and the interaction between drug and film excipient were evaluated. The films were also characterized by Fourier transform infrared spectroscopy (FT–IR). In vitro drug dissolution and release from the transdermal patches (coded C–L, C–T, H–L and H–T) were evaluated.

Results: There was significant difference between the batches in terms of in vitro drug release (p > 0.05). Dissolved drug was significantly higher in H-T film when compared to C-L film (p < 0.05). İn addition, drug release was significantly higher from H-T patch than from C-L patch (p < 0.05).

Conclusion: NE transdermal patches containing HEC and Transcutol® have been successfully formulated. They can potentially be used to deliver NE via transdermal route to decrease the side effects associated with the oral route of administration of the hormone

Keywords: Norethisterone, Transdermal delivery, Controlled release, Hormone therapy