Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-up
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) t...
Saved in:
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Sciendo
2017-12-01
|
| Series: | Acta Pharmaceutica |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/acph-2017-0033 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832570063223259136 |
|---|---|
| author | Badawi Aliaa A. Hegazy Mahmoud M. Louis Dina Eldegwy Mohammed A. |
| author_facet | Badawi Aliaa A. Hegazy Mahmoud M. Louis Dina Eldegwy Mohammed A. |
| author_sort | Badawi Aliaa A. |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-4f69b84480a24a00aefe82466c3f966a |
| institution | Kabale University |
| issn | 1846-9558 |
| language | English |
| publishDate | 2017-12-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Acta Pharmaceutica |
| spelling | doaj-art-4f69b84480a24a00aefe82466c3f966a2025-02-02T17:46:43ZengSciendoActa Pharmaceutica1846-95582017-12-0167451152510.1515/acph-2017-0033acph-2017-0033Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-upBadawi Aliaa A.0Hegazy Mahmoud M.1Louis Dina2Eldegwy Mohammed A.3Department of Pharmaceutics and Industrial Pharmacy Faculty of Pharmacy, Cairo University Cairo, EgyptResearch & Development Department, Mepaco-Medifood Company, El Sharkia, EgyptDepartment of Pharmaceutics and Industrial Pharmacy Faculty of Pharmacy, Cairo University Cairo, EgyptResearch & Development Department, Mepaco-Medifood Company, El Sharkia, EgyptL-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.https://doi.org/10.1515/acph-2017-0033l-carnitine-l-tartrateadsorbentscale-upcompression forceejection forcehygroscopic |
| spellingShingle | Badawi Aliaa A. Hegazy Mahmoud M. Louis Dina Eldegwy Mohammed A. Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-up Acta Pharmaceutica l-carnitine-l-tartrate adsorbent scale-up compression force ejection force hygroscopic |
| title | Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-up |
| title_full | Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-up |
| title_fullStr | Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-up |
| title_full_unstemmed | Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-up |
| title_short | Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-up |
| title_sort | solving manufacturing problems for l carnitine l tartrate to improve the likelihood of successful product scale up |
| topic | l-carnitine-l-tartrate adsorbent scale-up compression force ejection force hygroscopic |
| url | https://doi.org/10.1515/acph-2017-0033 |
| work_keys_str_mv | AT badawialiaaa solvingmanufacturingproblemsforlcarnitineltartratetoimprovethelikelihoodofsuccessfulproductscaleup AT hegazymahmoudm solvingmanufacturingproblemsforlcarnitineltartratetoimprovethelikelihoodofsuccessfulproductscaleup AT louisdina solvingmanufacturingproblemsforlcarnitineltartratetoimprovethelikelihoodofsuccessfulproductscaleup AT eldegwymohammeda solvingmanufacturingproblemsforlcarnitineltartratetoimprovethelikelihoodofsuccessfulproductscaleup |