Recent Advances in Dissolution Testing and Their Use to Improve In Vitro–In Vivo Correlations in Oral Drug Formulations

Ranjan, Alok; Jha, Prateek K.

doi:10.1007/s12247-021-09565-2

Cited by 6 publications

(6 citation statements)

References 179 publications

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“…Thiolated chitosan absorbs more water compared with chitosan, due to which it swells. The resulting increase in pore size helps in continuous and easy drug release from the matrix [ 53 ]. Other studies have shown that there are negative charges in the deep layer of the skin.…”

Section: Discussionmentioning

confidence: 99%

Fabrication of Tizanidine Loaded Patches Using Flaxseed Oil and Coriander Oil as a Penetration Enhancer for Transdermal Delivery

et al. 2021

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Transdermal drug delivery is important to maintain plasma drug concentrations for therapeutic efficacy. The current study reports the design, formulation, and evaluation of tizanidine transdermal patches formulated using chitosan and thiolated chitosan, ethyl cellulose (EC), polyvinylpyrrolidone (PVP), and Eudragit RL100 in different ratios. The tizanidine patches were formulated using flaxseed oil and coriander oil in the concentrations of 1% v/w, 2% v/w, 3% v/w, 4% v/w, 5% v/w, and 10% v/w. The patches were subjected to characterization of physicochemical property (thickness, weight uniformity, drug content, efficiency, percentage moisture uptake/loss), in vitro drug release and drug permeation, skin irritation, in vivo application, pharmacokinetics analysis, and stability studies. The results indicate that the interaction of thiolated chitosan with the negative charges of the skin opens the tight junctions of the skin, whereas flaxseed and coriander oils change the conformational domain of the skin. The novelty of this study is in the use of flaxseed and coriander oils as skin permeation enhancers for the formulation of tizanidine transdermal patches. The formulations follow non-Fickian drug release kinetics. The FTZNE23, FTZNE36 and FTZNE54, with 5% v/w flaxseed oil loaded formulations, exhibited higher flux through rabbit skin compared with FTZNE30, FTZNE35, FTZNE42, and FTZNE47, formulations loaded with 10% v/w coriander oil. The study concludes that flaxseed oil is a better choice for formulating tizanidine patches, offering optimal plasma concentration and therapeutic efficacy, and recommends the use of flaxseed and coriander oil based patches as a novel transdermal delivery system for tizanidine and related classes of drugs.

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Section: Discussionmentioning

confidence: 99%

Fabrication of Tizanidine Loaded Patches Using Flaxseed Oil and Coriander Oil as a Penetration Enhancer for Transdermal Delivery

et al. 2021

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“…This suggests that the use of the PLS regression algorithm is sufficient to build models with good predictive performance. Additionally, it was an indication that blindly increasing data may be incapable of improving the model prediction performance and may even decrease it, such as predictor set (2). The preceding statement provided additional evidence that data fusion modeling strategies were not fixed and that data selection should be made on a case-bycase basis.…”

Section: Bp-ann Model Based On the Multi-source Data Fusion Strategymentioning

confidence: 99%

“…1 Particularly, the in vitro dissolution profile is significant as it is linked to the in vivo therapeutic efficacy. 2 Currently, in vitro dissolution testing is widely used during drug development and implemented for controlling product quality. 3 Standard dissolution procedures, defined in the United States Pharmacopoeia (USP), are utilized for this purpose.…”

Section: Introductionmentioning

confidence: 99%

Dissolution profile prediction of sinomenine hydrochloride sustained release tablets, part II: a multisource data fusion approach

Wang

Zhang

et al. 2023

New J. Chem.

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“…Drugs belonging to BCS (biopharmaceutical classification system) II have high permeability but low solubility, of which absorption is generally limited by the dissolution process. Unfortunately, 30% of drugs on the market and 70% of drug candidates in the development pipeline fall into BCS II classification . To obtain sufficient exposure and achieve expected therapeutic effects, poorly absorbed drugs therefore require high doses, which may increase the incidence of side effects, especially for anticancer drugs.…”

mentioning

confidence: 99%

“…Unfortunately, 30% of drugs on the market and 70% of drug candidates in the development pipeline fall into BCS II classification. 2 To obtain sufficient exposure and achieve expected therapeutic effects, poorly absorbed drugs therefore require high doses, which may increase the incidence of side effects, especially for anticancer drugs. Cocrystallization is emerging as a potential technology for tailored modulation of drug properties.…”

mentioning

confidence: 99%

Superior Dissolution Behavior and Bioavailability of Pharmaceutical Cocrystals and Recent Regulatory Issues

Xia

Zhu

Wang

et al. 2021

ACS Med. Chem. Lett.

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Cocrystallization has been used extensively to optimize the physicochemical properties of active pharmaceutical ingredients (APIs), such as stability, dissolution, and bioavailability. This review summarizes the history and development of cocrystals, the differences between pharmaceutical cocrystals and salts, and the mechanism underlying the improvement of dissolution through cocrystallization. The correlation of in vitro dissolution and in vivo absorption data (IVIVC) of cocrystals has been discussed as well. Subsequently, guidelines for regulatory classification of cocrystals by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are introduced. Finally, d-α-tocopherol is used as an example to demonstrate the potential of cocrystals in patent generation.

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Recent Advances in Dissolution Testing and Their Use to Improve In Vitro–In Vivo Correlations in Oral Drug Formulations

Cited by 6 publications

References 179 publications

Fabrication of Tizanidine Loaded Patches Using Flaxseed Oil and Coriander Oil as a Penetration Enhancer for Transdermal Delivery

Fabrication of Tizanidine Loaded Patches Using Flaxseed Oil and Coriander Oil as a Penetration Enhancer for Transdermal Delivery

Dissolution profile prediction of sinomenine hydrochloride sustained release tablets, part II: a multisource data fusion approach

Superior Dissolution Behavior and Bioavailability of Pharmaceutical Cocrystals and Recent Regulatory Issues

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