Acta Pharmaceutica, Vol. 67 No. 4, 2017.
Original scientific paper
https://doi.org/10.1515/acph-2017-0033
Solving manufacturing problems for L-carnitine-L-tartrate to improve likelihood of successful product scale-up
ALIAA A. BADAWI
; Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt
MAHMOUD M. HEGAZY
; Research & Development Department, Mepaco-Medifood Company, El Sharkia, Egypt
DINA LOUIS
; Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt; Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy and Drug Technology, Heliopolis University for Sustainable Development
MOHAMMED A. ELDEGWY
; Research & Development Department, Mepaco-Medifood Company, El Sharkia, Egypt
Abstract
L-carnitine-L-tartrate, a non-essential amino acid, is hygroscopic. This causes a problem in tablet production due to pronounced adhesion of tablets to punches. A 33 full factorial design was adopted to suggest a tablet formulation. Three adsorbents were suggested (Aerosil 200, Aerosil R972, Talc) to reduce stickiness at three concentrations (1, 3 and 5 %), and three fillers (mannitol, Avicel PH 101, Dibasic calcium phosphate) were chosen to prepare 27 formulations. Micromeritic properties of formulations were studied, and tablets were prepared by wet granulation. Absence of picking, sticking or capping, recording of sufficient hardness, acceptable friability and tablet ejection force indicated formulation success. The resulting formulation prepared using Avicel PH 101 and 1 % Aerosil 200 was submitted to further investigation in order to choose the most suitable compression conditions using a 33 full factorial design. Variables included compression force, tableting rate and magnesium stearate (lubricant) concentration. The formulation prepared at compression force of 25 kN, using 2 % magnesium stearate, at a production rate of 30 tablets/ minute, was found to be the most appropriate scale up candidate.
Keywords
L-carnitine-L-tartrate; adsorbent; scale-up; compression force; ejection force; hygroscopic
Hrčak ID:
186326
URI
Publication date:
31.12.2017.
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