<abstract xmlns="http://www.w3.org/1999/xhtml"><p> 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 3<sup>3</sup> 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.</p></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.

Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-up

Acta Pharmaceutica

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

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...

Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-up

Publicado en línea: 11 ene 2018

Páginas: 511 - 525

DOI: https://doi.org/10.1515/acph-2017-0033

Palabras clave
L-carnitine-L-tartrate, adsorbent, scale-up, compression force, ejection force, hygroscopic

© by Dina Louis

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-up

Publicado en línea: 11 ene 2018

Páginas: 511 - 525

DOI: https://doi.org/10.1515/acph-2017-0033

Palabras claveL-carnitine-L-tartrate, adsorbent, scale-up, compression force, ejection force, hygroscopic

© by Dina Louis

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

Palabras clave
L-carnitine-L-tartrate, adsorbent, scale-up, compression force, ejection force, hygroscopic