Expert Design and Desirability Function Approach for the Development of Diazepam Thermally Sensitive Rectal Gel

Abstract

Aim: The aim of the present work was to develop an in situ thermosensitive rectal gel for diazepam by using Expert-design for improving three factors and a three-level process was formed by using a cold method. Methods & materials: Response surface design was utilized to investigate the effect of independent variables like sodium chloride (NaCl, X1), poloxamer 407 (F-127, X2) and diazepam (X3), on different dependent variables such as gelation temperature, mucoadhesive strength, drug content, along with permeation and stability. Results: The obtained results revealed that the addition of diazepam enhanced the gelation temperature of hydrogel while it decreased the gel strength and mucoadhesive force. Conclusion: It is suggested that in situ hydrogels may be suitable candidates for rectal delivery.

Keywords:

• diazepam
• gelling temperature
• poloxamer 407
• thermosensitive

Acknowledgments

The results provided in this paper were part of a student thesis (no. 3863) submitted at Tabriz University of Medical Sciences.

Financial & competing interests disclosure

The authors greatly acknowledge the financial support received from the Drug Applied Research Center of Tabriz University of Medical Sciences. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was showed in production of the manuscript.

Ethical conduct of research

This project was approved by the Ethics Committee of Tabriz University of Medical Sciences with the code number TBZMED.REC.1394.259. The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.