Holistic development of coal tar lotion by embedding design of experiments (DoE) technique: preclinical investigations

ABSTRACT

Background: The research work endeavors to develop a liquid dosage form of an efficacious antipsoriatic drug, i.e., coal tar, but having problems like variability and patient noncompliance.

Methods: The emulsion was prepared by the wet gum method from standardized coal tar. The optimized lotion obtained after sequential experimental designs was characterized for various dosage form and/or coal tar-related properties including efficacy.

Results: The formulation deposited more coal tar in the unit area of rat skin than marketed lotions. The efficacy of lotion in psoriasis animal models was more or equivalent to marketed lotions. The formulation showed one compartment body model dermatokinetics, nonirritancy after repeated applications, and stability at room conditions for a year.

Conclusion: The formulation with desired attributes was successfully developed.

KEYWORDS:

• Dermatokinetics
• Design of Experiments
• Lotion
• Mechanism
• Psoriasis

Acknowledgments

The authors are thankful to Dr. Kaiser Raza, assistant professor, Central University of Rajasthan, Ajmer, and their students for performing the ¹H₁ NMR studies. The various departments of Panjab University, Chandigarh, viz., Department of Geology, Centre for potential in excellence in Basic medical sciences and UGC centre of excellence in applications of nanomaterials, nanoparticles, and nanocomposites, and SAIF, CIL, and UCIM have helped in carrying the studies of research work and authors are thankful to their authorities and staff. Prof Bhupinder Singh Bhoop, one of the authors, gratefully acknowledges the generosity of M/s Stat-Ease Inc., Minneapolis, USA, for providing one perpetual license and multiple single annual licence of Design Expert® software, version 10.0 and he provided software to Mr. Gajanand Sharma, Panjab University, Chandigarh to perform optimization studies with his expert advice.

Author contributions

Mandeep Sharma: Carried out research work, analyze the data, and drafted the rough manuscript; Gajanand Sharma: Helped in formulation development, performing experiment and analysis of data, and manuscript preparation; and improvement and finalization of rough manuscript; Bhupinder Singh: DOE implementation; Vandana Dhiman: Carried out the cell line studies and helped in the relevant calculations; Sanjay Kumar Bhadada: Appropriate assistance in the cell line studies; and Om Prakash Katare: Conception of idea and assistance in the preparation of manuscript.

Declaration of interest

The authors have no 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This work was supported by University Grant Commission, New Delhi [F.4-1/2006 (BSR)/5-94/2007 (BSR) dated 03.05.2013 and 7858/UIPS date 14/3/14].