Formulation and characterization of transdermal patches for controlled delivery of duloxetine hydrochloride

Abstract

Background: Duloxetine hydrochloride is an antidepressant drug also approved for diabetic neuropathy, anxiety disorders, and fibromyalgia requiring repeated administration on chronic basis. The objective of this study was to develop a transdermal drug delivery system for duloxetine hydrochloride as a once daily dosage form. Methods: Transdermal patches were prepared by solvent evaporation method employing controlled release grades of HPMC in presence or absence of plasticizer PEG-400. FTIR and Differential scanning calorimetry ruled out drug polymer interactions. Standard procedures were used to analyze the prepared films for various physicochemical parameters, drug release (Franz diffusion cell) and skin irritation test. Results: The formulations were uniform in their physical characteristics with low water vapor absorption, moisture loss and water vapor transmission implying excellent quality and uniformity in patch characteristics. The patches were devoid of hypersensitivity reactions on rat skin. The in-vitro and ex-vivo drug release studies for all the formulations showed that the first dose of the drug was released in 2.0-3.0 h and nearly complete release (94%) was achieved in 24 h. Conclusions: Transdermal patches were successfully prepared for duloxetine hydrochloride and their evaluation suggested excellent quality and uniformity in patch characteristics. This can have potential applications in therapeutic arena offering advantages in terms of reduced dosing frequency, improved patient compliance and bioavailability.

Duloxetine hydrochloride loaded film forming dermal gel enriched with methylcobalamin and geranium oil attenuates paclitaxel-induced peripheral neuropathy in rats

“…Furthermore, the film forming gel through DDDS provides better release of drugs in a controlled manner over a longer period of time in comparison to conventional methods of topical delivery ( Ahmed and Khalid, 2014 ). Ideally, a drug having non-ionic behaviour with molecular weight (M w ) less than 600 Da, log P value in the range of 1–4, solubility in both oils and water and low melting point (< 220 °C) penetrates the skin effortlessly ( Singh and Bali, 2016 ). Evidences suggest that duloxetine hydrochloride possesses acceptable physicochemical and biopharmaceutical assets in terms of molecular weight (333.9 g/mol), log P (3.84), aqueous solubility (5 mg/mL) and melting point (162−162 °C) ( Singh and Bali, 2016 ).…”

“…Ideally, a drug having non-ionic behaviour with molecular weight (M w ) less than 600 Da, log P value in the range of 1–4, solubility in both oils and water and low melting point (< 220 °C) penetrates the skin effortlessly ( Singh and Bali, 2016 ). Evidences suggest that duloxetine hydrochloride possesses acceptable physicochemical and biopharmaceutical assets in terms of molecular weight (333.9 g/mol), log P (3.84), aqueous solubility (5 mg/mL) and melting point (162−162 °C) ( Singh and Bali, 2016 ). Henceforth, in this study, film forming polymer-based duloxetine hydrochloride gel has been designed to fabricate.…”

Transdermal patches: Design and current approaches to painless drug delivery

“…A transdermal patch is cut into three longitudinal strips: one from the right side, one from the left side, and one from the center. The length of each strip is measured (90). The following equation is used for flatness determination:…”

Development of Transdermal Patches for the Delivery of Chlorpheniramine in Infants using Hypromellose and Cassava Starch Composite Polymers

“…Some surface-active agents have been shown to affect tight junction permeability 8 . Previous studies have shown that mixtures of hydrophilic polymers and cassava starch can form suitable film-formers for improved transdermal drug delivery 9 and HPMC have been effectively used to formulate transdermal films of low dose drugs 9,10 .…”