Tags

Type your tag names separated by a space and hit enter

The influence of the API properties on the ODTs manufacturing from co-processed excipient systems.
AAPS PharmSciTech. 2012 Dec; 13(4):1120-9.AP

Abstract

Directly compressible co-processed excipient systems facilitate orodispersible tablets (ODTs) manufacturing. Despite several excipient systems available, it is reported that the incorporation of high drug dose into the tablet mass may negatively affect both disintegration and mechanical properties. Therefore the influence of drug properties on the quality of orodispersible tablets was investigated. Fast dissolving tablet matrix was made of a co-processed excipient system F-Melt. Two grades of F-Melt that differed in composition, particle shape, and specific surface area were used to form tablet matrix. Ibuprofen, diclofenac sodium, and diltiazem hydrochloride were chosen as model drugs of different physicochemical properties such as solubility, particle size, and shape. Ninety formulations containing 12.5, 25, or 50 wt% of the model drug and F-Melt type C or M were prepared by direct compression. The quality of tablets was examined on the base of disintegration time, wetting time, mechanical resistance and texture analysis. The results showed that F-Melt grade, drug solubility, and its dose had an influence on the quality of tablets. From ninety formulations prepared, only four batches containing F-Melt type C and 12.5 wt% of ibuprofen, diclofenac sodium, or diltiazem hydrochloride could be classified as ODTs. Their disintegration time ranged from 41 to 144 s. In the case of F-Melt type M, tablets disintegrating within 101 s of friability below 1% could be prepared only if 12.5 wt% of diclofenac sodium was incorporated into the tablet mass.

Authors+Show Affiliations

Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Jagiellonian University, Medical College, Cracow, Poland. akrupa@cm-uj.krakow.plNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22941425

Citation

Krupa, Anna, et al. "The Influence of the API Properties On the ODTs Manufacturing From Co-processed Excipient Systems." AAPS PharmSciTech, vol. 13, no. 4, 2012, pp. 1120-9.
Krupa A, Jachowicz R, Pędzich Z, et al. The influence of the API properties on the ODTs manufacturing from co-processed excipient systems. AAPS PharmSciTech. 2012;13(4):1120-9.
Krupa, A., Jachowicz, R., Pędzich, Z., & Wodnicka, K. (2012). The influence of the API properties on the ODTs manufacturing from co-processed excipient systems. AAPS PharmSciTech, 13(4), 1120-9. https://doi.org/10.1208/s12249-012-9831-2
Krupa A, et al. The Influence of the API Properties On the ODTs Manufacturing From Co-processed Excipient Systems. AAPS PharmSciTech. 2012;13(4):1120-9. PubMed PMID: 22941425.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The influence of the API properties on the ODTs manufacturing from co-processed excipient systems. AU - Krupa,Anna, AU - Jachowicz,Renata, AU - Pędzich,Zbigniew, AU - Wodnicka,Krystyna, Y1 - 2012/09/01/ PY - 2012/02/20/received PY - 2012/07/24/accepted PY - 2012/9/4/entrez PY - 2012/9/4/pubmed PY - 2013/5/17/medline SP - 1120 EP - 9 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 13 IS - 4 N2 - Directly compressible co-processed excipient systems facilitate orodispersible tablets (ODTs) manufacturing. Despite several excipient systems available, it is reported that the incorporation of high drug dose into the tablet mass may negatively affect both disintegration and mechanical properties. Therefore the influence of drug properties on the quality of orodispersible tablets was investigated. Fast dissolving tablet matrix was made of a co-processed excipient system F-Melt. Two grades of F-Melt that differed in composition, particle shape, and specific surface area were used to form tablet matrix. Ibuprofen, diclofenac sodium, and diltiazem hydrochloride were chosen as model drugs of different physicochemical properties such as solubility, particle size, and shape. Ninety formulations containing 12.5, 25, or 50 wt% of the model drug and F-Melt type C or M were prepared by direct compression. The quality of tablets was examined on the base of disintegration time, wetting time, mechanical resistance and texture analysis. The results showed that F-Melt grade, drug solubility, and its dose had an influence on the quality of tablets. From ninety formulations prepared, only four batches containing F-Melt type C and 12.5 wt% of ibuprofen, diclofenac sodium, or diltiazem hydrochloride could be classified as ODTs. Their disintegration time ranged from 41 to 144 s. In the case of F-Melt type M, tablets disintegrating within 101 s of friability below 1% could be prepared only if 12.5 wt% of diclofenac sodium was incorporated into the tablet mass. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/22941425/The_influence_of_the_API_properties_on_the_ODTs_manufacturing_from_co_processed_excipient_systems_ L2 - https://dx.doi.org/10.1208/s12249-012-9831-2 DB - PRIME DP - Unbound Medicine ER -