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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Jain, Rohit Wu, Zimei Bork, Olaf Tucker, Ian G. |
| Description | Country affiliation: New Zealand Author Affiliation: Jain R ( School of Pharmacy, University of Otago, Dunedin, New Zealand. rohit.jain@otago.ac.nz) |
| Abstract | Penethamate (PNT) is a diethylaminoethyl ester prodrug of benzylpenicillin used to treat bovine mastitis via the intramuscular route. Because of its instability, PNT products must be reconstituted before administration and the reconstituted injection has a short shelf life (7 days at 2-8°C). The purpose of this paper was to investigate whether the stability of PNT can be improved in order to achieve a chemically stable ready-to-use aqueous-based PNT formulation or at least to extend the shelf life of the reconstituted suspension. A chemical stability study of PNT in aqueous-based solutions as a function of pH, buffer strength, solvent mixtures and temperature, supported by studies of its solubility in mixed solvents, allowed predictions of the shelf life of PNT solution and suspension formulations. PNT degraded in aqueous solutions by several pathways over the pH range 2.0-9.3 with a V-shaped pH-rate profile and a minimum pH of around 4.5. The stability of PNT solutions in mixed solvents was greater than in aqueous solutions. For example, in propylene glycol:citrate buffer (60:40, v/v, pH 4.5), the half-life of PNT was 4.3 days compared with 1.8 days in aqueous buffer. However, solubility of PNT in the mixed solvent was higher than that in aqueous solution and this had an adverse effect on the stability of suspensions. By judicious choosing of pH and mixed solvent, it is possible to achieve a storage life of a PNT suspension of 5.5 months at 5°C, not sufficient for a ready-to-use product but a dramatic improvement in the storage life of the reconstituted product. |
| File Format | HTM / HTML |
| ISSN | 03639045 |
| Issue Number | 1 |
| Volume Number | 38 |
| e-ISSN | 15205762 |
| Journal | Drug Development and Industrial Pharmacy |
| Language | English |
| Publisher | Taylor & Francis |
| Publisher Date | 2012-01-01 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Discipline Pharmacology Esters Chemistry Excipients Penicillin G Analogs & Derivatives Prodrugs Solutions Buffers Chemistry, Pharmaceutical Drug Stability Half-life Hydrogen-ion Concentration Pharmacokinetics Solubility Solvents Suspensions Temperature Water Journal Article Research Support, Non-u.s. Gov't |
| Content Type | Text |
| Resource Type | Article |
| Subject | Organic Chemistry Drug Discovery Pharmacology Pharmaceutical Science |
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