Tablet dissolution against USP and FDA specifications: molecular mechanisms & dependencies

How nutrients influence it

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What it does

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Recorded relationships

Where it participates (unsigned role)

In an accelerated stability study, form C was converted to the thermodynamically stable and least soluble form A with increased temperature and moisture, the transformation was significantly increased at constant temperature and humidity when trace amounts of form A were already present, four of the seven products tested contained trace amounts of form A, in some tablets transformation was so quick that it reduced shelf life to less than one month, and tablet dissolution of those products was reduced to the extent that it did not comply with USP and FDA specifications.
Mebendazole polymorph C → Mebendazole polymorph A source_derived_draftungraded
Experimental context and source evidence
evidence_span
{"source_cache": "artifacts/mebendazole-research/19691117.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "6005cbf9afb4151467910164f873d0956382c3bcc10cac8514326385b32e32b1", "start_char": 0, "end_char": 1296, "text_sha256": "6005cbf9afb4151467910164f873d0956382c3bcc10cac8514326385b32e32b1"}
experimental_model
Accelerated stability study of mebendazole tablets under ICH storage conditions
exposure
Storage at 30 degrees with 65% relative humidity and at 40 degrees with 75% relative humidity
limitations
Solid-state kinetics on marketed products, modelled with the Johnson-Mehl-Avrami-Erofeyev-Kolmogorov equation. It measures dissolution rather than patient outcome.
nutrient_topic
Mebendazole research collection; topical membership is not evidence of a direct clinical effect, and mebendazole is recorded separately from albendazole, from the benzimidazole class and from its own crystal forms. · Mebendazole
organism
Pharmaceutical product
plain_language
The working form of the drug turns into the useless form on the shelf, faster if a trace of the useless form is already there.
primary_references
[mbz-p19691117] Characterization of polymorph transformations that decrease the stability of tablets containing the WHO essential drug mebendazole. (2010). https://pubmed.ncbi.nlm.nih.gov/19691117/ DOI: 10.1002/jps.21899
tissue_or_cell_type
Tablets
Mebendazole: the tubulin it binds, why that is selective, the crystal form that decides whether any of it works, and the off-target that became an oncology programme (2026-09-22) · lines 381–392
AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. Not publisher full text. · supports · Accelerated stability study of mebendazole tablets under ICH storage conditions · source_derived_draft · unverified_draft
### mbz-crystal-form-sets-solubility In an accelerated stability study, form C was converted to the thermodynamically stable and least soluble form A with increased temperature and moisture, the transformation was significantly increased at constant temperature and humidity when trace amounts of form A were already present, four of the seven products tested contained trace amounts of form A, in some tablets transformation was so quick that it reduced shelf life to less than one month, and tablet dissolution of those products was reduced to the extent that it did not comply with USP and FDA specifications. Condition category: normal nutrient_topic: Mebendazole research collection; topical membership is not evidence of a direct clinical effect, and mebendazole is recorded separately from albendazole, from the benzimidazole class and from its own crystal forms. plain_language: The working form of the drug turns into the useless form on the shelf, faster if a trace of the useless form is already there. organism: Pharmaceutical product tissue_or_cell_type: Tablets experimental_model: Accelerated stability study of mebendazole tablets under ICH storage conditions limitations: Solid-state kinetics on marketed products, modelled with the Johnson-Mehl-Avrami-Erofeyev-Kolmogorov equation. It measures dissolution rather than patient outcome. exposure: Storage at 30 degrees with 65% relative humidity and at 40 degrees with 75% relative humidity evidence_span: {"source_cache": "artifacts/mebendazole-research/19691117.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "6005cbf9afb4151467910164f873d0956382c3bcc10cac8514326385b32e32b1", "start_char": 0, "end_char": 1296, "text_sha256": "6005cbf9afb4151467910164f873d0956382c3bcc10cac8514326385b32e32b1"} [mbz-p19691117] Characterization of polymorph transformations that decrease the stability of tablets containing the WHO essential drug mebendazole. (2010). https://pubmed.ncbi.nlm.nih.gov/19691117/ DOI: 10.1002/jps.21899
Complete structured claim and evidence
Of four raw materials of mebendazole examined, three were polymorph C and the other was polymorph A or a mixture of forms A and B, with X-ray powder diffractometry and infrared spectroscopy indicating form B while the much slower powder dissolution suggested polymorph A; the literature prescribes use of polymorph C pharmaceutically, generic manufacturers should be aware that forms other than C are still available on the market, and all four mebendazole tablets then available in South Africa contained polymorph C.
Mebendazole polymorph A → Aqueous solubility and dissolution rate of the solid drug source_derived_draftungraded
Experimental context and source evidence
evidence_span
{"source_cache": "artifacts/mebendazole-research/9876612.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "c0cb5ad093307edd2cbaee474418c3086cd524c606eaddd1cae7186ed962fd26", "start_char": 0, "end_char": 666, "text_sha256": "c0cb5ad093307edd2cbaee474418c3086cd524c606eaddd1cae7186ed962fd26"}
experimental_model
Preformulation analysis of four mebendazole raw materials and four marketed tablets
exposure
X-ray powder diffractometry, infrared spectroscopy and powder dissolution
limitations
A small survey in one country at one time. It also shows the analytical methods disagreeing with each other on one sample, which is recorded.
nutrient_topic
Mebendazole research collection; topical membership is not evidence of a direct clinical effect, and mebendazole is recorded separately from albendazole, from the benzimidazole class and from its own crystal forms. · Mebendazole
organism
Pharmaceutical product
plain_language
The inactive form is still sold as raw material, and the tests used to tell the forms apart do not always agree.
primary_references
[mbz-p9876612] Identification of the mebendazole polymorphic form present in raw materials and tablets available in South Africa. (1998). https://pubmed.ncbi.nlm.nih.gov/9876612/ DOI: 10.3109/03639049809085647
tissue_or_cell_type
Raw material and tablets
Mebendazole: the tubulin it binds, why that is selective, the crystal form that decides whether any of it works, and the off-target that became an oncology programme (2026-09-22) · lines 394–405
AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. Not publisher full text. · supports · Preformulation analysis of four mebendazole raw materials and four marketed tablets · source_derived_draft · unverified_draft
### mbz-wrong-form-reaches-market Of four raw materials of mebendazole examined, three were polymorph C and the other was polymorph A or a mixture of forms A and B, with X-ray powder diffractometry and infrared spectroscopy indicating form B while the much slower powder dissolution suggested polymorph A; the literature prescribes use of polymorph C pharmaceutically, generic manufacturers should be aware that forms other than C are still available on the market, and all four mebendazole tablets then available in South Africa contained polymorph C. Condition category: normal nutrient_topic: Mebendazole research collection; topical membership is not evidence of a direct clinical effect, and mebendazole is recorded separately from albendazole, from the benzimidazole class and from its own crystal forms. plain_language: The inactive form is still sold as raw material, and the tests used to tell the forms apart do not always agree. organism: Pharmaceutical product tissue_or_cell_type: Raw material and tablets experimental_model: Preformulation analysis of four mebendazole raw materials and four marketed tablets limitations: A small survey in one country at one time. It also shows the analytical methods disagreeing with each other on one sample, which is recorded. exposure: X-ray powder diffractometry, infrared spectroscopy and powder dissolution evidence_span: {"source_cache": "artifacts/mebendazole-research/9876612.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "c0cb5ad093307edd2cbaee474418c3086cd524c606eaddd1cae7186ed962fd26", "start_char": 0, "end_char": 666, "text_sha256": "c0cb5ad093307edd2cbaee474418c3086cd524c606eaddd1cae7186ed962fd26"} [mbz-p9876612] Identification of the mebendazole polymorphic form present in raw materials and tablets available in South Africa. (1998). https://pubmed.ncbi.nlm.nih.gov/9876612/ DOI: 10.3109/03639049809085647
Complete structured claim and evidence

The events it takes part in

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Situations it appears in

Low-supply and faulty-machinery situations recorded in the chapters where this component plays a part.

In the sources

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This is a research prototype built from draft material. It is not medical advice, and its statements still await verification against the original studies.

Tablet dissolution against USP and FDA specifications