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A quality by design approach to develop topical creams via hot-melt extrusion technology.
Eur J Pharm Sci 2019; 136:104948EJ

Abstract

The advantages of hot-melt extrusion technology (HME) over conventional techniques to develop topical semisolids have been established. However, this technique is not widely used for semisolid production. Therefore, the aim of this novel work was to develop creams using the melt extrusion technology while applying Quality by Design (QbD) principles to study the effects of the extrusion process parameters on the product characteristics. The model drug selected was hydrocortisone acetate. A 23 factorial design was considered for the factor influence study, which resulted in eight formulations to be extruded. Of the process parameters considered, the temperature of zone 2 had a significant influence on the work of adhesion of the creams. A similar permeation profile was obtained for all the formulations with the formulations following a diffusion based drug release mechanism. The results from the size distribution graph indicated stable cream formulations. In conclusion, this technology coupled with a design of experiments approach could be utilized to study how the extrusion process parameters could be modified to develop consistent topical creams with ideal product characteristics.

Authors+Show Affiliations

Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, MS 38677, USA.Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, MS 38677, USA.Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, MS 38677, USA.Dave C. Swalm School of Chemical Engineering, Mississippi State University, Oktibbeha County, MS 39762, USA.Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, MS 38677, USA.Dave C. Swalm School of Chemical Engineering, Mississippi State University, Oktibbeha County, MS 39762, USA.Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, MS 38677, USA; Pii Center for Pharmaceutical Technology, School of Pharmacy, The University of Mississippi, Oxford, MS 38677, USA. Electronic address: marepka@olemiss.edu.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31173868

Citation

Mendonsa, Nicole S., et al. "A Quality By Design Approach to Develop Topical Creams Via Hot-melt Extrusion Technology." European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, vol. 136, 2019, p. 104948.
Mendonsa NS, Pradhan A, Sharma P, et al. A quality by design approach to develop topical creams via hot-melt extrusion technology. Eur J Pharm Sci. 2019;136:104948.
Mendonsa, N. S., Pradhan, A., Sharma, P., Prado, R. M. B., Murthy, S. N., Kundu, S., & Repka, M. A. (2019). A quality by design approach to develop topical creams via hot-melt extrusion technology. European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, 136, p. 104948. doi:10.1016/j.ejps.2019.06.002.
Mendonsa NS, et al. A Quality By Design Approach to Develop Topical Creams Via Hot-melt Extrusion Technology. Eur J Pharm Sci. 2019 Aug 1;136:104948. PubMed PMID: 31173868.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A quality by design approach to develop topical creams via hot-melt extrusion technology. AU - Mendonsa,Nicole S, AU - Pradhan,Adwait, AU - Sharma,Purnendu, AU - Prado,Rosa M B, AU - Murthy,S Narasimha, AU - Kundu,Santanu, AU - Repka,Michael A, Y1 - 2019/06/04/ PY - 2018/11/27/received PY - 2019/04/11/revised PY - 2019/06/02/accepted PY - 2019/6/8/pubmed PY - 2019/6/8/medline PY - 2019/6/8/entrez KW - Critical process parameters KW - Globule size measurements KW - Hot-melt extrusion KW - Quality by design approach KW - Topical creams KW - Work of adhesion SP - 104948 EP - 104948 JF - European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences JO - Eur J Pharm Sci VL - 136 N2 - The advantages of hot-melt extrusion technology (HME) over conventional techniques to develop topical semisolids have been established. However, this technique is not widely used for semisolid production. Therefore, the aim of this novel work was to develop creams using the melt extrusion technology while applying Quality by Design (QbD) principles to study the effects of the extrusion process parameters on the product characteristics. The model drug selected was hydrocortisone acetate. A 23 factorial design was considered for the factor influence study, which resulted in eight formulations to be extruded. Of the process parameters considered, the temperature of zone 2 had a significant influence on the work of adhesion of the creams. A similar permeation profile was obtained for all the formulations with the formulations following a diffusion based drug release mechanism. The results from the size distribution graph indicated stable cream formulations. In conclusion, this technology coupled with a design of experiments approach could be utilized to study how the extrusion process parameters could be modified to develop consistent topical creams with ideal product characteristics. SN - 1879-0720 UR - https://www.unboundmedicine.com/medline/citation/31173868/A_quality_by_design_approach_to_develop_topical_creams_via_hot-melt_extrusion_technology L2 - https://linkinghub.elsevier.com/retrieve/pii/S0928-0987(19)30211-8 DB - PRIME DP - Unbound Medicine ER -