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Influence of Dissolution Media and Presence of Alcohol on the In Vitro Performance of Pharmaceutical Products Containing an Insoluble Drug.
J Pharm Sci. 2018 01; 107(1):507-511.JP

Abstract

The purpose of this investigation is to determine how the dissolution media may influence the release rate of an insoluble drug in in vitro conditions. Some oral dosage forms containing ibuprofen, a molecule that shows pH-dependent solubility, are tested. They are evaluated in different media to simulate the gastrointestinal transit at paddle rotation speeds of 50 and 100 rpm. Moreover, the potential effect of different ethanol concentrations on drug release is tested. The dissolution profiles of the tablets show a similar behavior in water (pH 1.0) and phosphate buffer (pH 4.5) where the 2 doses are not completely dissolved. The soft capsules show a different behavior: a certain amount of ibuprofen, which is in solution inside the capsule, reprecipitates in water and in the pH 4.5 buffer. Instead, ibuprofen dissolves rapidly in the pH 6.8 buffer from all the formulations. In the water-ethanol solutions, the dissolution curves show a valuable increase in the drug dissolved at higher ethanol concentrations.

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Authors+Show Affiliations

Friuli V
Department of Drug Sciences, University of Pavia, Viale Taramelli 12, Pavia 27100, Italy. Electronic address: valeria.friuli@unipv.it.
Bruni G
Department of Chemistry, Physical Chemistry Section, University of Pavia, Viale Taramelli 16, Pavia 27100, Italy.
Musitelli G
Department of Drug Sciences, University of Pavia, Viale Taramelli 12, Pavia 27100, Italy.
Conte U
Department of Drug Sciences, University of Pavia, Viale Taramelli 12, Pavia 27100, Italy.
Maggi L
Department of Drug Sciences, University of Pavia, Viale Taramelli 12, Pavia 27100, Italy.

MeSH

CapsulesChemistry, PharmaceuticalDrug CompoundingDrug LiberationEthanolHydrogen-Ion ConcentrationIbuprofenPharmaceutical PreparationsSolubilityTabletsWater

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28624418

Citation

Friuli, Valeria, et al. "Influence of Dissolution Media and Presence of Alcohol On the in Vitro Performance of Pharmaceutical Products Containing an Insoluble Drug." Journal of Pharmaceutical Sciences, vol. 107, no. 1, 2018, pp. 507-511.
Friuli V, Bruni G, Musitelli G, et al. Influence of Dissolution Media and Presence of Alcohol on the In Vitro Performance of Pharmaceutical Products Containing an Insoluble Drug. J Pharm Sci. 2018;107(1):507-511.
Friuli, V., Bruni, G., Musitelli, G., Conte, U., & Maggi, L. (2018). Influence of Dissolution Media and Presence of Alcohol on the In Vitro Performance of Pharmaceutical Products Containing an Insoluble Drug. Journal of Pharmaceutical Sciences, 107(1), 507-511. https://doi.org/10.1016/j.xphs.2017.06.001
Friuli V, et al. Influence of Dissolution Media and Presence of Alcohol On the in Vitro Performance of Pharmaceutical Products Containing an Insoluble Drug. J Pharm Sci. 2018;107(1):507-511. PubMed PMID: 28624418.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Influence of Dissolution Media and Presence of Alcohol on the In Vitro Performance of Pharmaceutical Products Containing an Insoluble Drug. AU - Friuli,Valeria, AU - Bruni,Giovanna, AU - Musitelli,Giorgio, AU - Conte,Ubaldo, AU - Maggi,Lauretta, Y1 - 2017/06/15/ PY - 2017/03/28/received PY - 2017/05/22/revised PY - 2017/06/05/accepted PY - 2017/6/19/pubmed PY - 2018/7/25/medline PY - 2017/6/19/entrez KW - dissolution rate KW - poorly water-soluble drugs KW - solubility KW - tablet SP - 507 EP - 511 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 107 IS - 1 N2 - The purpose of this investigation is to determine how the dissolution media may influence the release rate of an insoluble drug in in vitro conditions. Some oral dosage forms containing ibuprofen, a molecule that shows pH-dependent solubility, are tested. They are evaluated in different media to simulate the gastrointestinal transit at paddle rotation speeds of 50 and 100 rpm. Moreover, the potential effect of different ethanol concentrations on drug release is tested. The dissolution profiles of the tablets show a similar behavior in water (pH 1.0) and phosphate buffer (pH 4.5) where the 2 doses are not completely dissolved. The soft capsules show a different behavior: a certain amount of ibuprofen, which is in solution inside the capsule, reprecipitates in water and in the pH 4.5 buffer. Instead, ibuprofen dissolves rapidly in the pH 6.8 buffer from all the formulations. In the water-ethanol solutions, the dissolution curves show a valuable increase in the drug dissolved at higher ethanol concentrations. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/28624418/Influence_of_Dissolution_Media_and_Presence_of_Alcohol_on_the_In_Vitro_Performance_of_Pharmaceutical_Products_Containing_an_Insoluble_Drug_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3549(17)30435-5 DB - PRIME DP - Unbound Medicine ER -