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Recovery of Active Pharmaceutical Ingredients from Unused Solid Dosage-Form Drugs.

ABSTRACT: The concept of drug recycle by recovering active pharmaceutical ingredients (APIs) from unused tablets and capsules was demonstrated using acetaminophen, tetracycline HCl, and (R,S)-(±)-ibuprofen as case examples. The recovery process comprised three core unit operations: solid-liquid extraction, filtration, and crystallization. Recovery yields of 58.7 wt %, 73.1 wt %, and 67.6 wt % for acetaminophen, tetracycline HCl, and (R,S)-(±)-ibuprofen were achieved, respectively. More importantly, all of the APIs were of high purity based on high-performance liquid chromatography assay. The crystal forms of the recovered APIs were in conformity with the standards.

SUBMITTER: Pratama DE

PROVIDER: S-EPMC7675532 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Recovery of Active Pharmaceutical Ingredients from Unused Solid Dosage-Form Drugs.

Pratama Dhanang Edy DE Hsieh Wen-Chen WC Elmaamoun Ahmed A Lee Hung Lin HL Lee Tu T

ACS omega 20201106 45

The concept of drug recycle by recovering active pharmaceutical ingredients (APIs) from unused tablets and capsules was demonstrated using acetaminophen, tetracycline HCl, and (R,S)-(±)-ibuprofen as case examples. The recovery process comprised three core unit operations: solid-liquid extraction, filtration, and crystallization. Recovery yields of 58.7 wt %, 73.1 wt %, and 67.6 wt % for acetaminophen, tetracycline HCl, and (R,S)-(±)-ibuprofen were achieved, respective ...[more]

PMID: 33225146

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Project description:The assumptions and models for solubility modelling or prediction in systems using non-polar solvents, or water and complex triterpene and other active pharmaceutical ingredients as solutes aren't well studied. Furthermore, the assumptions concerning heat capacity effects (negligibility, experimental values or approximations) are explored, using non-polar solvents (benzene), or water as reference solvents, for systems with solute melting points in the range of 306-528?K and molecular weights in the range of 90-442?g/mol. New empirical estimation methods for the ?fusCpi of APIs are presented which correlate the solute molecular masses and van der Waals surface areas with ?fusCpi . Separate empirical parameters were required for oxygenated and non-oxygenated solutes. Subsequently, the predictive capabilities of the various approaches to solubility modelling for complex pharmaceuticals, for which data is limited, are analysed. The solute selection is based on a principal component analysis, considering molecular weights, fusion temperatures, and solubilities in a non-polar solvent, alcohol, and water, where data was available. New NRTL-SAC parameters were determined for selected steroids, by regression. The original UNIFAC, modified UNIFAC (Dortmund), COSMO-RS (OL), and COSMO-SAC activity coefficient predictions are then conducted, based on the availability of group constants and sigma profiles. These are undertaken to assess the predictive capabilities of these models when each assumption concerning heat capacity is employed. The predictive qualities of the models are assessed, based on the mean square deviation and provide guidelines for model selection, and assumptions concerning phase equilibrium, when designing solid-liquid separators for the pharmaceutical industry on process simulation software. The most suitable assumption regarding ?fusCpi was found to be system specific, with modified UNIFAC (Dortmund) performing well in benzene as a solvent system, while original UNIFAC performs better in aqueous systems. Original UNIFAC outperforms other predictive models tested in the triterpene/steroidal systems, with no significant influence from the assumptions regarding ?fusCpi .

Dataset Information

Recovery of Active Pharmaceutical Ingredients from Unused Solid Dosage-Form Drugs.

Publications

Recovery of Active Pharmaceutical Ingredients from Unused Solid Dosage-Form Drugs.

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