Correlation of dissolution and disintegration results for an immediate-release tablet

Nickerson, Beverly; Kong, Angela; Gerst, Paul H.; Kao, Shangming

doi:10.1016/j.jpba.2017.12.017

Cited by 29 publications

(15 citation statements)

References 10 publications

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“…In one formulation, PG starch from Vendor 1 (termed model Formulation-1) was used while in the other formulation Vendor 2 (termed model Formulation-2) was employed. Since the API in the formulations is categorised as BCS class 3, the use of disintegration as a surrogate test to dissolution is employed (Nickerson et al, 2018). Disintegration results for both the model formulation tablets manufactured using different PG starch values are provided in Figure 6.…”

Section: Excipient Variability and Correlation With Performance-disintegration Testingmentioning

confidence: 99%

Pregelatinized Starch: Variability in Gelatinization and its Influence on Product Performance

Saravanan¹,

Muthudoss²,

Khullar³

et al. 2021

ijrps

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Starch and its derivatives are one of the significant excipients used in the pharmaceutical formulations due to their multi-purpose functionalities. The purpose of this study is two-fold: (1) Firstly, to propose a systematic approach in understanding the material properties of a starch derivative (pregelatinised starch/PGS) using analytical ‘toolbox’ as part of ‘alternative supplier sourcing’, and secondly (2) To demonstrate the effect of PGS from different vendors on the tablet disintegration using model formulations. Contextually, a two-tier characterisation procedure is generally considered as a prerequisite for establishing the sameness of the material obtained either from different batches or from various vendors. Primarily, the sameness between typical quality-control tests and compendial requirements are to be established. If similar, then sameness between the functional characteristics is to be established. In this context, the PGS from two vendors met the specifications, and there were no differences for the test results in the certificates of analysis. However, when subjected to functionality assessment, the two lots were found to be distinctly different. The influence of the functional property variations was further exemplified from viscosity results of raw material. Furthermore, this difference was even more evident when the model formulations were subjected to disintegration testing. The similarity in compendial tests but significant differences in functionality characteristics for the PGS of two vendors can be unravelled by considering variations in particle size, crystallinity, starch retrogradation and these changes are potentially attributed to the differences in the gelatinisation procedures adopted by the vendors.

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Section: Excipient Variability and Correlation With Performance-disintegration Testingmentioning

confidence: 99%

Pregelatinized Starch: Variability in Gelatinization and its Influence on Product Performance

Saravanan¹,

Muthudoss²,

Khullar³

et al. 2021

ijrps

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“…All formulations met the official compendium requirements for tablets (disintegration time less than 30 min for tablets). Reference, generic and similar products disintegrated in 13 formulations. In addition to its use as a binder/diluent, microcrystalline cellulose also has some lubricant and disintegrant properties that make it useful in tableting [25].…”

Section: Physical Tests (Weight Uniformity and Disintegration)mentioning

confidence: 99%

“…Therefore, a multipoint analysis is necessary to obtain detail of drug release through dissolution profiles [12]. In pharmaceutical industry, dissolution profiles are used for formulation development and optimization, drug quality and stability assessment, formulation and manufacturing process changes [13][14][15].…”

Section: Introductionmentioning

confidence: 99%

Desenvolvimento de nova metodologia para avaliação da dissolução in vitro de comprimidos de Besilato de Amlodipina comercializados em Salvador/Bahia/Brasil, empregando planejamento experimental fatorial

Dias

Júnior

Oliveira

et al. 2020

BJD

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“…Nevertheless, Nickerson et al were able to obtain a relationship between disintegration and dissolution for a rapidly dissolving immediate-release tablet with a highly soluble drug (BCS class I), thus justifying the use of disintegration in lieu of dissolution testing (33). In their work, given the stated characteristics, drug release from the DF was shown to be limited by disintegration.…”

Section: Relationship Between Disintegration and Dissolutionmentioning

confidence: 99%

The Significance of Disintegration Testing in Pharmaceutical Development

Silva¹,

Webster²,

Bou‐Chacra³

et al. 2018

Dissolution Technol.

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Disintegration is a physical process related to the mechanical breakdown of a tablet or granulate particle into smaller particles. This review investigates disintegration mechanisms, pharmacopeial use of the disintegration test and scientific studies showing its utility and potential as a pharmaceutical performance test. With a proper dosage form understanding and demonstration/justification of the mechanistic details of drug dissolution from a dosage form, dissolution testing might be replaced by disintegration testing as a performance test. However, more research is needed to make disintegration test results more mechanistically valuable in pharmaceutical development. This might lead to a reliable performance test and potentially an in-vivo predictive disintegration test in the future.

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Correlation of dissolution and disintegration results for an immediate-release tablet

Cited by 29 publications

References 10 publications

Pregelatinized Starch: Variability in Gelatinization and its Influence on Product Performance

Pregelatinized Starch: Variability in Gelatinization and its Influence on Product Performance

Desenvolvimento de nova metodologia para avaliação da dissolução in vitro de comprimidos de Besilato de Amlodipina comercializados em Salvador/Bahia/Brasil, empregando planejamento experimental fatorial

The Significance of Disintegration Testing in Pharmaceutical Development

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