Dissolution testing for sustained or controlled release oral dosage forms and correlation with in vivo data: Challenges and opportunities

Zahirul, M.; Khan, Imran

doi:10.1016/0378-5173(96)04561-9

Cited by 71 publications

(23 citation statements)

References 45 publications

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“…The caveat is that the lowest possible concentration of surfactant to achieve 75-80% API release within a reasonable dissolution test time must be used (17). As expected, increasing the amount of SLS in the dissolution medium resulted in an increased rate and extent of dissolution of NVP as has been reported for other BCS Class II compounds (14,15,17).…”

Section: Concentration Of Surfactantmentioning

confidence: 81%

“…The selection of an appropriate dissolution medium for assessing the dissolution rate of a sparingly soluble API is challenging as it is often difficult to achieve sink conditions (8,14,15). The addition of a small quantity of a surfactant to the dissolution test medium for testing these compounds has been suggested as an appropriate way to better simulate the GIT environment and to achieve sink conditions in vitro (14,16).…”

Section: Concentration Of Surfactantmentioning

confidence: 99%

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Development and Assessment of a USP Apparatus 3 Dissolution Test Method for Sustained-Release Nevirapine Matrix Tablets

Mwila¹,

Khamanga²,

Walker³

2016

Dissolution Technol.

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Dissolution testing is a quality control tool used to assess batch-to-batch performance of dosage forms, thereby providing continued assurance of product quality. Analytical methods for the assessment of pharmaceutical product quality must be validated according to regulatory guidelines to ensure that tests are reliable and valid. Agitation rate, mesh pore size, surfactant concentration, and dissolution medium molarity are experimental parameters that may affect nevirapine (NVP) release and were investigated and optimized to ensure that consistent, reliable, and valid results using Apparatus 3 were produced. Agitation rate was investigated to establish an equivalent response to that observed for NVP release using Apparatus 2 at 50 rpm. A reciprocation rate of 5-10 dpm produced dissolution profiles that were similar to those observed using Apparatus 2. An increase in the molarity of the dissolution medium slightly increased the release rate of NVP, and a 50 mM buffer maintained at pH values mimicking gastrointestinal tract (GIT) conditions was selected for all experiments. With the addition of 2% sodium lauryl sulfate (SLS) to the dissolution medium, >80% NVP was released from the tablets over the test period. The NVP release rate increased with an increase in the mesh pore size; however, the extent of release was not affected by this parameter. Dissolution test samples were analyzed using HPLC, and dissolution methods were validated for NVP stability in the dissolution medium, specificity, linearity and range, repeatability, intermediate precision, and accuracy as defined by ICH. The dissolution method used for testing NVP tablets can be regarded as an appropriate tool for the evaluation of sustained-release (SR) NVP formulations and the impact of formulation composition and product quality attributes on drug release.

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Section: Concentration Of Surfactantmentioning

confidence: 81%

Section: Concentration Of Surfactantmentioning

confidence: 99%

Development and Assessment of a USP Apparatus 3 Dissolution Test Method for Sustained-Release Nevirapine Matrix Tablets

Mwila¹,

Khamanga²,

Walker³

2016

Dissolution Technol.

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“…PRO dissolution was lowered by the effect of salts in the dissolution medium, especially common ion effect like chloride ion in HBS (31). A major role in the decrease of PRO dissolution was from the common ion effect and ionic strength influencing the dissolution of ionized drugs (32,33). The variation in HCT release in this experiment was due to the difference of gel structure in the matrix tablet during dissolution.…”

Section: Discussionmentioning

confidence: 79%

Double-Layered Matrix of Shellac Wax-Lutrol in Controlled Dual Drug Release

Phaechamud

Choncheewa

2015

AAPS PharmSciTech

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Abstract. Double-layered matrix tablets prepared from shellac wax-lutrol were fabricated using a molding technique, and the release of hydrochlorothiazide and propranolol HCl from the inner tablet or outer layer was studied. The simultaneous determination of dual drug release was measured with first derivative UV spectrophotometry. The tablet containing shellac wax as the outer tablet and lutrol as the inner tablet showed more appropriate drug release and the size of the inner layer influenced the rate of drug release. In addition, the aqueous solubility of the drug and the components of the inner tablet or outer layer affected the drug release behavior. Most of the double-layered tablets exhibited the drug-release pattern which fitted well with zero-order kinetic due to the restriction of the release surface. Biphasic drug release pattern was found in the tablet of which the outer layer rapidly eroded. The drug dissolution data from drug-loaded-outer layer could predict the dissolution time for the outer layer of drug-loaded inner part of double-layered matrix tablet. Incorporation of lutrol increased the drug release from shellac wax matrix, and the zero-order release was attained by fabricating it into a double-layered tablet.

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“…Although disintegration process can be studied in vitro, the interaction between physiological parameters and the solid dosage forms affect drug delivery profile and the reproducibility of drug release (8). If the intended site of drug release is the colon, it must be taken into consideration the prandial state and gastric emptying of dosage forms.…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, the disintegration of the solid dosage form must be taken into consideration since this process provides the drug release for the absorption (6,7). For this reason in vitro tests are needed although the results are not fully comparable to the physiological conditions (8). More reliable data are obtained when human studies are carried out, since the bioavailability of drugs from colonic dosage forms is dependent on gastric emptying, small intestinal transit time and drug release profile (9).…”

Section: Introductionmentioning

confidence: 98%

Enteric Coated Magnetic HPMC Capsules Evaluated in Human Gastrointestinal Tract by AC Biosusceptometry

et al. 2006

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Dissolution testing for sustained or controlled release oral dosage forms and correlation with in vivo data: Challenges and opportunities

Cited by 71 publications

References 45 publications

Development and Assessment of a USP Apparatus 3 Dissolution Test Method for Sustained-Release Nevirapine Matrix Tablets

Development and Assessment of a USP Apparatus 3 Dissolution Test Method for Sustained-Release Nevirapine Matrix Tablets

Double-Layered Matrix of Shellac Wax-Lutrol in Controlled Dual Drug Release

Enteric Coated Magnetic HPMC Capsules Evaluated in Human Gastrointestinal Tract by AC Biosusceptometry

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