The Significance of Disintegration Testing in Pharmaceutical Development

Silva, Daniela Amaral; Webster, Gregory K.; Bou‐Chacra, Nádia Araci; Löbenberg, Raimar

doi:10.14227/dt250318p30

Cited by 31 publications

(21 citation statements)

References 24 publications

(46 reference statements)

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“…Thus, the FNV A, D, E, and K formulated with vitamins extracted from the agricultural products followed by mixing the synthetic vitamins could be within the dispersion specifications. The rate of dissolution influenced the absorption rate and the efficacy of the tablet products, which significantly influenced its bioavailability (Silva, Webster, Bou‐Chacra, & Löbenberg, 2018). Hence, the current study subsequently evaluated the bio‐accessibility and the intestinal absorption in the gastrointestinal tract fluid by using an in vitro biomimetic system.…”

Section: Resultsmentioning

confidence: 99%

Physicochemical properties and bioavailability of naturally formulated fat‐soluble vitamins extracted from agricultural products for complementary use for natural vitamin supplements

Lee

Shin

Chun³

et al. 2020

Food Science & Nutrition

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Vitamins are essential to human body, and 13 vitamins have been identified and classified as fat-soluble vitamins (A, E, D, and K) and water-soluble vitamins (B-group vitamins and vitamin C) according to their solubility (Turner & Mathiasson, 2000). In particular, fat-soluble vitamins are necessary for regulating various cell metabolisms, which include anti-oxidation, cell signaling, and the modulation of the immune system (Chadare et al., 2019; Turner, King, & Mathiasson, 2001). Vitamin A and its precursor, which is β-carotene, are predominantly found in plants, and they are mainly necessary for protecting the retina as well as scavenging free radicals (Akhtar

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Section: Resultsmentioning

confidence: 99%

Physicochemical properties and bioavailability of naturally formulated fat‐soluble vitamins extracted from agricultural products for complementary use for natural vitamin supplements

Lee

Shin

Chun³

et al. 2020

Food Science & Nutrition

View full text Add to dashboard Cite

show abstract

“…During a wet granulation process, the API and excipients come in close contact in such a way that the excipients can influence the API dissolution. After the tablet disintegrates, the drug dissolution depends also on the granules disintegration/deaggregation [33,34]. As a result, a microclimate can be created around the granulate particle, which was seen in the dextrose formulations.…”

Section: Discussionmentioning

confidence: 99%

Biphasic Dissolution as an Exploratory Method during Early Drug Product Development

et al. 2020

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Dissolution testing is a major tool used to assess a drug product’s performance and as a quality control test for solid oral dosage forms. However, compendial equipment and methods may lack discriminatory power and the ability to simulate aspects of in vivo dissolution. Using low buffer capacity media combined with an absorptive phase (biphasic dissolution) increases the physiologic relevance of in vitro testing. The purpose of this study was to use non-compendial and compendial dissolution test conditions to evaluate the in vitro performance of different formulations. The United States Pharmacopeia (USP)-recommended dissolution method greatly lacked discriminatory power, whereas low buffer capacity media discriminated between manufacturing methods. The use of an absorptive phase in the biphasic dissolution test assisted in controlling the medium pH due to the drug removal from the aqueous medium. Hence, the applied non-compendial methods were more discriminative to drug formulation differences and manufacturing methods than conventional dissolution conditions. In this study, it was demonstrated how biphasic dissolution and a low buffer capacity can be used to assess in vitro drug product performance differences. This can be a valuable approach during the early stages of drug product development for investigating in vitro drug release with improved physiological relevance.

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“…The first method will need an additional agent, such as lactose [ 4 ], to help the observation, and the disintegration is stated to begin when the release of the agent is first observed. On the other hand, the second method does not need an additional agent and will need a longer observation time since the disintegration requires that the material be completely invisible by unaided eyes [ 112 ]. Based on a comparison, it is suggested to use the full disintegration (second) method since there is no additional agent that may affect the disintegration process.…”

Section: Disintegration Processmentioning

confidence: 99%

Preparation, Properties and Potential of Carrageenan-Based Hard Capsules for Replacing Gelatine: A Review

et al. 2021

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Intense efforts to develop alternative materials for gelatine as a drug-delivery system are progressing at a high rate. Some of the materials developed are hard capsules made from alginate, carrageenan, hypromellose and cellulose. However, there are still some disadvantages that must be minimised or eliminated for future use in drug-delivery systems. This review attempts to review the preparation and potential of seaweed-based, specifically carrageenan, hard capsules, summarise their properties and highlight their potential as an optional main component of hard capsules in a drug-delivery system. The characterisation methods reviewed were dimensional analysis, water and ash content, microbial activity, viscosity analysis, mechanical analysis, scanning electron microscopy, swelling degree analysis, gel permeation chromatography, Fourier-transform infrared spectroscopy and thermal analysis. The release kinetics of the capsule is highlighted as well. This review is expected to provide insights for new researchers developing innovative products from carrageenan-based hard capsules, which will support the development goals of the industry.

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The Significance of Disintegration Testing in Pharmaceutical Development

Cited by 31 publications

References 24 publications

Physicochemical properties and bioavailability of naturally formulated fat‐soluble vitamins extracted from agricultural products for complementary use for natural vitamin supplements

Physicochemical properties and bioavailability of naturally formulated fat‐soluble vitamins extracted from agricultural products for complementary use for natural vitamin supplements

Biphasic Dissolution as an Exploratory Method during Early Drug Product Development

Preparation, Properties and Potential of Carrageenan-Based Hard Capsules for Replacing Gelatine: A Review

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