Transdermal Film Making Method

Oct 13, 2025 by windailys.com 107 views

Formulation and Evaluation in Vitro Transdermal Films of Sodium Diclofenac Using Chitosan Polymers and Polyvinyl Alcohol Cross-Linking with Sodium Tripoli Phosphate

Introduction

Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used to reduce inflammation and pain. Diclofenac sodium is one of the most effective NSAIDs available, but its use is often limited by gastrointestinal side effects and first-pass metabolism in the liver. Transdermal drug delivery offers a promising alternative, allowing for controlled release of the drug and reduced risk of side effects. In this study, we aim to formulate and evaluate in vitro transdermal films of sodium diclofenac using chitosan polymers, polyvinyl alcohol, and sodium tripoli phosphate.

Research Purposes

The primary objective of this study is to develop a transdermal film of sodium diclofenac using a combination of chitosan polymers, polyvinyl alcohol, and sodium tripoli phosphate. By applying cross-linking techniques, we hope to create a film that provides an optimal drug release profile. This study will investigate the effects of varying the ratio of chitosan to polyvinyl alcohol and the cross-linking time on the properties of the transdermal film.

Transdermal Film Making Method

The transdermal films were prepared by mixing chitosan solutions and polyvinyl alcohol solutions, along with glycerin and sodium diclofenac. The mixture was then dried to form a film. To trigger a cross-linking reaction, a sodium tripoli phosphate solution was added, and the film was dried again. A total of six different formulas were prepared, with variations in the ratio of chitosan to polyvinyl alcohol and the cross-linking time.

Film Character Evaluation

The properties of the transdermal films were evaluated using several parameters, including organoleptic observation, weight test, thickness, humidity, folding power, interaction between materials, and the level of active substances. The release of sodium diclofenac was measured using Franz diffusion cells in phosphate buffer (pH 7.4).

Results and Analysis

Organoleptic observations revealed that the transdermal films had a yellow color, with varying levels of smoothness. Formulas F1, F2, F3, and F4 produced films with fine textures, while F5 and F6 had a rough texture. Formulas F1, F2, F5, and F6 showed flexible nature, meeting the requirements of the folding power test, while F3 and F4 did not meet these requirements.

All transdermal films met the criteria for uniformity of weight, thickness, and humidity. The F1 formula had the lowest humidity level, at 1.07 ± 0.193%. Additionally, F1 showed the optimal cumulative percent of 94.30% with a release flux of 894.42 μg/cm² per hour in a 10-hour permeation time.

The in vitro penetration test indicated that the formula with a cross-linking time of 10 minutes showed better results and flux compared to the cross-linking time of 20 minutes. The process of releasing drugs from transdermal films followed the erosion mechanism with zero order. FTIR analysis also showed the absence of significant interactions between sodium diclofenac and the excipients used.

Conclusion

This study demonstrates the successful formulation of transdermal films of sodium diclofenac using chitosan polymers, polyvinyl alcohol, and sodium tripoli phosphate. The results show that the transdermal film with a 10-minute cross-linking time provides a better release profile than the 20-minute cross-linking time, making it a more effective choice to increase the bioavailability of drugs. This study highlights the potential of developing a better drug delivery system that minimizes side effects and increases patient comfort.

Future Directions

Future studies should focus on optimizing the formulation and evaluation of transdermal films of sodium diclofenac. This may involve investigating the effects of varying the ratio of chitosan to polyvinyl alcohol and the cross-linking time on the properties of the transdermal film. Additionally, in vivo studies should be conducted to evaluate the efficacy and safety of the transdermal film in humans.

Limitations

This study has several limitations. Firstly, the in vitro penetration test was conducted using Franz diffusion cells, which may not accurately reflect the in vivo situation. Secondly, the study only investigated the effects of varying the ratio of chitosan to polyvinyl alcohol and the cross-linking time on the properties of the transdermal film. Future studies should investigate the effects of other variables, such as the concentration of sodium diclofenac and the type of excipients used.

Conclusion

In conclusion, this study demonstrates the successful formulation and evaluation of in vitro transdermal films of sodium diclofenac using chitosan polymers, polyvinyl alcohol, and sodium tripoli phosphate. The results show that the transdermal film with a 10-minute cross-linking time provides a better release profile than the 20-minute cross-linking time, making it a more effective choice to increase the bioavailability of drugs. This study highlights the potential of developing a better drug delivery system that minimizes side effects and increases patient comfort.
Q&A: Formulation and Evaluation in Vitro Transdermal Films of Sodium Diclofenac Using Chitosan Polymers and Polyvinyl Alcohol Cross-Linking with Sodium Tripoli Phosphate

Q: What is the purpose of this study?

A: The primary objective of this study is to develop a transdermal film of sodium diclofenac using a combination of chitosan polymers, polyvinyl alcohol, and sodium tripoli phosphate. By applying cross-linking techniques, we hope to create a film that provides an optimal drug release profile.

Q: What are the key components of the transdermal film?

A: The transdermal film is composed of chitosan polymers, polyvinyl alcohol, glycerin, sodium diclofenac, and sodium tripoli phosphate. The combination of these components is designed to provide a controlled release of sodium diclofenac.

Q: How were the transdermal films prepared?

A: The transdermal films were prepared by mixing chitosan solutions and polyvinyl alcohol solutions, along with glycerin and sodium diclofenac. The mixture was then dried to form a film. To trigger a cross-linking reaction, a sodium tripoli phosphate solution was added, and the film was dried again.

Q: What were the key findings of this study?

A: The study found that the transdermal film with a 10-minute cross-linking time provided a better release profile than the 20-minute cross-linking time. The film also showed a high level of flexibility and met the requirements of the folding power test.

Q: What are the potential benefits of this transdermal film?

A: The transdermal film has the potential to provide a controlled release of sodium diclofenac, reducing the risk of side effects and increasing patient comfort. It also has the potential to increase the bioavailability of the drug.

Q: What are the limitations of this study?

A: The study has several limitations, including the use of in vitro penetration tests and the investigation of only a limited number of variables. Future studies should investigate the effects of other variables, such as the concentration of sodium diclofenac and the type of excipients used.

Q: What are the future directions for this research?

A: Future studies should focus on optimizing the formulation and evaluation of transdermal films of sodium diclofenac. This may involve investigating the effects of varying the ratio of chitosan to polyvinyl alcohol and the cross-linking time on the properties of the transdermal film. Additionally, in vivo studies should be conducted to evaluate the efficacy and safety of the transdermal film in humans.

Q: What are the potential applications of this transdermal film?

A: The transdermal film has the potential to be used for the treatment of various conditions, including pain and inflammation. It may also be used for the treatment of other conditions, such as arthritis and fibromyalgia.

Q: What are the potential advantages of this transdermal film over other delivery systems?

A: The transdermal film has several potential advantages over other delivery systems, including its ability to provide a controlled release of the drug and its potential to reduce the risk of side effects. It also has the potential to increase patient comfort and compliance.

Q: What are the potential challenges associated with the development of this transdermal film?

A: The development of the transdermal film may be associated with several challenges, including the need to optimize the formulation and evaluation of the film. Additionally, the film may require further testing and validation before it can be used in humans.

Q: What are the potential regulatory implications of this transdermal film?

A: The transdermal film may be subject to regulatory approval before it can be used in humans. The regulatory implications of the film will depend on the specific requirements of the regulatory agency and the country in which it is being developed.