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Purpose <p>The purpose of this study was to develop and evaluate cilnidipine-impregnated transdermal patches with a sustained drug delivery system as an alternative to oral administration, which is characterized by the effects of first-pass and fluctuating plasma drug concentrations. The study aimed to determine an optimal polymeric formulation that would be used in the long-term antihypertensive treatment.</p> Methods <p>The solvent casting technique was used to prepare cilnidipine transdermal patches in varying ratios comprising hydroxypropyl methylcellulose (HPMC), ethyl cellulose (EC), polyvinylpyrrolidone (PVP), and Eudragit RS 100. The patches were tested in terms of physicochemical and mechanical performance, such as thickness, weight uniformity, folding endurance, percentage elongation, moisture content, moisture uptake, and drug content. FT-IR spectroscopy was used to determine the drug-excipient compatibility. The in-vitro studies on drug release were conducted on a modified diffusion assembly, and the kinetics of drug release were studied using mathematical modeling. The stability studies were conducted under accelerated ICH conditions in the ICH guidelines.</p> Results <p>The formulations were all found to have good physicochemical properties and a homogenous distribution of drugs with an 85.6–92.4% content of drug. Formulation F6 had the best mechanical strength, flexibility, and drug content of 92.4%. In-vitro release experiments revealed that the diffusion was cumulative, yielding a 92.71% cumulative drug release over 12&#xa0;h, which followed a non-Fickian diffusion process. The stability studies showed no substantial differences in the drug content and release profile over three months.</p> Conclusion <p>The optimized cilnidipine transdermal patch showed excellent stability and sustained drug release, which offers the possibility of using the patch as a permanent treatment for hypertension.</p>

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Development and In-Vitro Categorization of Cilnidipine-loaded Transdermal Patches: Design, Evaluation, and Performance Assessment

  • 期刊论文

  • 发表日期：

    2026年4月7日

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  • Lalchand D Devhare,
  • Sachin Hiradeve,
  • Vaibhav Uplanchiwar,
  • Vinod Thakare,
  • Namrata S Mane,
  • Pravinkumar B Suruse,
  • Kurtika Channe

摘要

Purpose

The purpose of this study was to develop and evaluate cilnidipine-impregnated transdermal patches with a sustained drug delivery system as an alternative to oral administration, which is characterized by the effects of first-pass and fluctuating plasma drug concentrations. The study aimed to determine an optimal polymeric formulation that would be used in the long-term antihypertensive treatment.

Methods

The solvent casting technique was used to prepare cilnidipine transdermal patches in varying ratios comprising hydroxypropyl methylcellulose (HPMC), ethyl cellulose (EC), polyvinylpyrrolidone (PVP), and Eudragit RS 100. The patches were tested in terms of physicochemical and mechanical performance, such as thickness, weight uniformity, folding endurance, percentage elongation, moisture content, moisture uptake, and drug content. FT-IR spectroscopy was used to determine the drug-excipient compatibility. The in-vitro studies on drug release were conducted on a modified diffusion assembly, and the kinetics of drug release were studied using mathematical modeling. The stability studies were conducted under accelerated ICH conditions in the ICH guidelines.

Results

The formulations were all found to have good physicochemical properties and a homogenous distribution of drugs with an 85.6–92.4% content of drug. Formulation F6 had the best mechanical strength, flexibility, and drug content of 92.4%. In-vitro release experiments revealed that the diffusion was cumulative, yielding a 92.71% cumulative drug release over 12 h, which followed a non-Fickian diffusion process. The stability studies showed no substantial differences in the drug content and release profile over three months.

Conclusion

The optimized cilnidipine transdermal patch showed excellent stability and sustained drug release, which offers the possibility of using the patch as a permanent treatment for hypertension.