Sheikh KAa, Saringat Bb, Bukhari NIc
a. Department of Pharmaceutics, The School of Pharmacy, University of London, WC1N 1AX, London, UK. b. Department of Pharmaceutics, The School of Pharmaceutical Sciences, University Science Malaysia, Penang, Malaysia. c. Department of Pharmaceutics, The school of Pharmacy and Allied Health Sciences, International Medical University, Kuala Lumpur, Malaysia.
Keywords: Quality by Design (QbD), Design of experiment, Palm–olein, Liquid paraffin, polymorphism, Maltese crosses.

Semisolid formulations of palm–olein were prepared using design of experiment (DoE) methodology. The influence of formulation aids (emulsifier) and the processing variables (mixing and cooling) were investigated on the physicochemical properties of the formulated systems. The stable semisolid appearance was the response variable. The systems were characterised by microscopy, DSC, Rheology, and XRD. The factorial design generated a matrix of 22 experiments to investigate physicochemical properties of the systems. The systems formed stable semisolids (no syneresis), unstable semisolids showing syneresis or structured fluids, depending on the concentration of stearic acid and the preparation technique. The stable semisolids contained a-crystalline lamellar structure, not present in the unstable structured fluids. In addition, syneretic semisolids showed plate-like crystals, implying pressure sensitivity, associated with polymorphism in the stearic acid. The stable semisolids showed mixture of amorphous and crystalline stearic acid. In contrast, pure amorphous or crystalline stearic acid was present in the unstable semisolids and the structured fluids respectively (confirmed by XRD). Mode of mixing and the concentration of stearic acid appeared to be critical factors (p<0.01). DoE predicted a combination of factors to achieve stable semisolid systems. Confirmatory experiments yielded results within 1% of the predicted responses, demonstrating the reliability of the software.

Article Information

Identifiers and Pagination:
First Page:301
Last Page:319
Publisher Id:JAppPharm (2011 ). 3. 301-319
Article History:
Received:April 20, 2011
Accepted:July 1, 2011
Collection year:2011
First Published:July 11, 2011

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Editor in Chief
Prof. Dr. Cornelia M. Keck (Philipps-Universität Marburg)
Marburg, Germany


Welcome to the research group of Prof. Dr. Cornelia M. Keck in Marburg. Cornelia M. Keck is a pharmacist and obtained her PhD in 2006 from the Freie Universität (FU) in Berlin. In 2009 she was appointed as Adjunct Professor for Pharmaceutical and Nutritional Nanotechnology at the University Putra Malaysia (UPM) and in 2011 she obtained her Venia legendi (Habilitation) at the Freie Universität Berlin and was appointed as a Professor for Pharmacology and Pharmaceutics at the University of Applied Sciences Kaiserslautern. Since 2016 she is Professor of Pharmaceutics and Biopharmaceutics at the Philipps-Universität Marburg. Her field of research is the development and characterization of innovative nanocarriers for improved delivery of poorly soluble actives for healthcare and cosmetics. Prof. Keck is executive board member of the German Association of Nanotechnology (Deutscher Verband Nanotechnologie), Vize-chairman of the unit „Dermocosmetics“ at the German Society of Dermopharmacy, active member in many pharmaceutical societies and member of the BfR Committee for Cosmetics at the Federal Institute for Risk Assessment (BfR).

Journal Highlights
Abbreviation: J App Pharm
Frequency: Annual 
Current Volume: 9 (2017)
Next scheduled volume: December, 2018 (Volume 10)
Back volumes: 1-9
Starting year: 2009
Nature: Online 
Submission: Online  
Language: English

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