Correlation and Prediction of Moisture-Mediated Dissolution Stability for Benazepril Hydrochloride Tablets

Li, Shoufeng; Wei, Bill; Fleres, Santo; Comfort, Ann R.; Royce, Alan E.

doi:10.1023/b:pham.0000022408.91151.64

Cited by 16 publications

(12 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Haque and Roos (2006) recently speculated that freeze-dried (FD) materials might have a higher amount of hydrogen bonding sites available for water molecules in sorption than spray-dried (SD) materials. Indeed, even a small increase in moisture content of a drug above a critical value of 3% was shown to significantly decrease its dissolution rate (Li, Wei, Fleres, Comfort, & Royce, 2004). Consequently, a less exothermic response due to either higher moisture content of the powder, or a reduced number of available hydrogen bonding sites, could have major implications in the wetting mechanism and kinetics of food powders, which in turn might slow down their dissolution process.…”

Section: Introductionmentioning

confidence: 99%

Solution calorimetry: A novel perspective into the dissolution process of food powders

Marabi

Mayor

Raemy

et al. 2007

Food Research International

View full text Add to dashboard Cite

Section: Introductionmentioning

confidence: 99%

Solution calorimetry: A novel perspective into the dissolution process of food powders

Marabi

Mayor

Raemy

et al. 2007

Food Research International

View full text Add to dashboard Cite

“…Water affected tablet dissolution by its interaction with APIs or excipients, as well as the tablet's porosity and mechanical strength. 44,45 A recent study by Okada et al showed that the sprayed water droplet had different evaporation rate, and the low drying air temperature would result in the spread of unevaporated droplets throughout the drying tower. 46 The presence of water will produce dry and wet phases in the powder.…”

Section: Multivariate Analysis Of Existing Data On Factors Affecting mentioning

confidence: 99%

Effect of Spray Drying Conditions on Physical Properties of Panax notoginseng Saponin (PNS) Powder and the Intra-Batch Dissolution Variability of PNS Hydrophilic Matrix Tablet

Yang

Wang

et al. 2021

DDDT

View full text Add to dashboard Cite

Purpose: Understanding raw material variability and its impact on product quality are crucial for developing robust pharmaceutical processes. This work aimed to study the effects of spray drying conditions on properties of the spray dried Panax notoginseng saponin (PNS) powders as well as the subsequent intra-batch dissolution variability of PNS hydrophilic matrix tablets. Methods: The Plackett-Burman design was applied to screen the critical process parameters (CPPs). Then, the Box-Behnken design was used to investigate the relationship between the CPPs and the physiochemical properties of spray dried PNS powders. The PNS hydrophilic matrix tablets containing 57% spray dried PNS powders were directly compressed. The partial least squares (PLS) regression was used to uncover the hidden multivariate relationships among the CPPs, intermediate powder properties, and tablet quality attributes. Results: The identified CPPs were the feed concentration, the inlet air temperature, and the atomization pressure. It was found that the CPPs exerted little impact on chemical properties of spray dried PNS powders, but had significant impact on physical properties, such as particle size, specific surface area, bulk density, hygroscopicity, and inter-particle porosity, etc. Latent variable modeling results revealed that the high inlet air temperature of spray drying process could produce PNS powders with low moisture content and high hygroscopicity, which were beneficial to reduce the intra-batch dissolution variability of PNS hydrophilic matrix tablets. Finally, a design space of the spray drying process was built in order to ensure the dissolution consistency. Conclusion:Our research provided a reference for improving the spray drying conditions in order to ensure the dissolution consistency of the PNS hydrophilic matrix tablet.

show abstract

“…The absorption of moisture can affect the properties of the powders used in pharmaceutical processing, such as compaction, blending, bulk density and flow [2][3][4][5]. For some drugs taken as oral solids, absorbed water can affect dissolution, disintegration and chemical stability [6][7][8][9][10]. Water has a wide-ranging impact on physical and chemical properties and must therefore be accounted for at all stages of the drug substance and product manufacture as well as the shelf life of the product.…”

Section: Introductionmentioning

confidence: 99%

Crystalline Forms of Trazodone Dihydrates

Plater

Harrison

2021

Molecules

View full text Add to dashboard Cite

In this study, treatment of anhydrous trazodone powder with ammonium carbamate in warm water crystallised two new polymorphs or dihydrates of trazodone after 5 h, whose structures were determined by X-ray single crystal diffraction. Each dihydrate contains infinite zigzag hydrogen-bonded chains of water molecules, which are stabilised by the N4 acceptor atom of the piperazine ring and the pendant carbonyl O1 atom of the triazole ring, as well as other water molecules. The strong dipole moment expected for the O1 atom makes it a good hydrogen bond acceptor for stabilising the chains of water molecules. Each molecule of trazodone has a similar conformation in both hydrates, except for the propyl chains, which adopt different conformations: anti-gauche in the β hydrate (triazole N-C-C-C and C-C-C-piperazine N) and anti-anti in the γ hydrate. Both piperazine rings adopt chair conformations, and the exocyclic N-C bonds are in equatorial orientations. The Hirshfeld surfaces and two-dimensional fingerprint plots for the polymorphs were calculated using CrystalExplorer17, which indicated contacts significantly shorter than the sum of the van der Waals radii in the vicinity of the piperazine N4 and triazole O1 atoms corresponding to the strong hydrogen bonds accepted by these atoms.

show abstract

Correlation and Prediction of Moisture-Mediated Dissolution Stability for Benazepril Hydrochloride Tablets

Cited by 16 publications

References 11 publications

Solution calorimetry: A novel perspective into the dissolution process of food powders

Solution calorimetry: A novel perspective into the dissolution process of food powders

Effect of Spray Drying Conditions on Physical Properties of Panax notoginseng Saponin (PNS) Powder and the Intra-Batch Dissolution Variability of PNS Hydrophilic Matrix Tablet

Crystalline Forms of Trazodone Dihydrates

Contact Info

Product

Resources

About