Dissolution test for site-specific release isoniazid pellets in USP apparatus 3 (reciprocating cylinder): Optimization using response surface methodology

Joshi, Amita; Pund, Swati; Nivsarkar, Manish; Vasu, Kamala K.; Shishoo, C. J.

doi:10.1016/j.ejpb.2007.11.020

Cited by 41 publications

(17 citation statements)

References 12 publications

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“…The use of dissolution test can speed up the formulation development, enabling a prompt identification of potential problems in drug release (3). In vitro release testing is also a very important tool for batch to batch quality control (1,2,4).…”

Section: Introductionmentioning

confidence: 99%

“…The operation involves programming the agitation rate (in dip per minute, dpm) of the ups and downs for the inner tube inside the outer tube. At the upstroke, the bottom mesh in the inner tube moves upward to contact the tested form and at the downstroke, the sample leaves the mesh and floats freely within the inner tube, allowing the tested form to be studied through a moving medium (3,46). Defined volumes of dissolution medium are withdrawn at regular intervals prior to drug substance dosage.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of Three Dissolution Apparatuses for Testing Calcium Phosphate Pellets used as Ibuprofen Delivery Systems

Chevalier

Viana

Artaud³

et al. 2009

AAPS PharmSciTech

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Abstract. Porous calcium phosphate pellets were produced according to two granulation processes (low and high shear wet granulations) and drug loaded with five ibuprofen contents (1.75%, 7%, 12.5%, 22%, and 36%) in order to ensure both bone defect filling and local drug delivery. The drug-release kinetics from the two types of pellets was studied using three dissolution apparatuses: paddle apparatus, reciprocating cylinder, and flow-through cell. The paper compared the three dissolution methods and considered the effect of the granulation process on the ibuprofen-release kinetics. Dissolution data were analyzed using the Weibull function as well as the difference (f1) and similarity (f2) factors. Dissolution kinetics was not influenced by the granulation process, regardless of the dissolution apparatus and of the drug content. The comparison of the three dissolution devices indicated that ibuprofen was released faster from granules loaded with 36% of drug content with the reciprocating apparatus, due to the disintegration of the granules occurring during the dissolution test. For the other drug contents, dissolution profiles were not significantly different from one apparatus to another. However, the flowthrough cell seemed to be more suitable for the drug-release study of implantable materials.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Comparison of Three Dissolution Apparatuses for Testing Calcium Phosphate Pellets used as Ibuprofen Delivery Systems

Chevalier

Viana

Artaud³

et al. 2009

AAPS PharmSciTech

View full text Add to dashboard Cite

show abstract

“…The dissolution samples were analysed by validated first derivative spectrophotometeric method and drug release was calculated. The analytical method was found to be specific, linear in the concentration range of 5-50 μg/ml, precise (% CV: 1.05-1.73 for 0.1 N HCl and 1.23-1.65 in PBS, pH 6.8) and accurate (98.5-102.0% for 0.1 N HCl and 98.2-102.5% in PBS, pH 6.8) (15).…”

Section: In Vitro Drug Release Studymentioning

confidence: 92%

“…Also, the linear regression plots between observed and predicted values of the response properties were drawn using MS-Excel ver. 2010 (15).…”

Section: Statistical Data Analysis and Validation Of The Optimizationmentioning

confidence: 99%

Melt-in-Mouth Multi-particulate System for the Treatment of ADHD: A Convenient Platform for Pediatric Use

2015

Self Cite

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Abstract. Generally, pellets obtained from extrusion/spheronization, containing microcrystalline cellulose (MCC), do not disintegrate. An attempt has been made to develop melt-in-mouth pellets of taste-masked atomoxetine hydrochloride, using extrusion-spheronization, for pediatric patients. Melt-in-mouth pellets were prepared using extrusion-spheronization method and optimized using 3 3 FFD. MCC (X 1 , %), mannitol (X 2 , %) and Indion 414: Pharmaburst 500 ratio (X 3 , ratio) were the factors (independent variables) studied, whereas responses studied (dependent variables) were friability (Y1, %), yield (Y2, %) shape (Y3, roundness) in vitro disintegration time (Y4, seconds). The optimized formulation obtained from FFD was characterized for friability, shape and morphology, in vitro disintegration time, porosity, moisture uptake, in vitro release study and in vivo taste and disintegration time in healthy human volunteers. Randomized, two-treatment, two-sequence, two-period, single dose, crossover sensory evaluation study of taste-masked melt-in-mouth pellet was carried out in 10 healthy human subjects. A statistically significant polynomial mathematical relationship was generated between the factors and responses to obtain an optimized formulation. The optimized formulation was characterized (in vitro and in vivo) and exhibited a rapid drug release in vitro attributed to fast disintegration of pellets and high solubility of drug in 0.1 N HCl and buffer (pH 6.8). In vivo, 40% of volunteers ranked taste-masked optimized formulation as slightly bitter while 60% ranked it as no taste. The optimized pellets were conveniently administered in volunteers and exhibited rapid in-vivo disintegration in the oral cavity. Melt-in-mouth pellets can be a used as a platform technology for administering drugs to paediatric patients accurately and conveniently resulting in patient compliance.

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“…The basket holds the sample and rotates in a round flask containing the dissolution medium (35). Samples (150 mg) were dispersed in 2.5 mL of distilled water and placed in a dialysis tube.…”

Section: In Vitro Release Studymentioning

confidence: 99%

Improving Oral Bioavailability and Pharmacokinetics of Liposomal Metformin by Glycerolphosphate–Chitosan Microcomplexation

et al. 2013

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Abstract. The purpose of this study was to develop a new delivery system capable of improving bioavailability and controlling release of hydrophilic drugs. Metformin-loaded liposomes were prepared and to improve their stability surface was coated with chitosan cross-linked with the biocompatible β-glycerolphosphate. X-ray diffraction, differential scanning calorimetry, as well as rheological analysis were performed to investigate interactions between chitosan and β-glycerolphosphate molecules. The entrapment of liposomes into the chitosan-β-glycerolphosphate network was assessed by scanning electron microscopy and transmission electron microscopy. Swelling and mucoadhesive properties as well as drug release were evaluated in vitro while the drug oral bioavailability was evaluated in vivo on Wistar rats. Results clearly showed that, compared to control, the proposed microcomplexes led to a 2.5-fold increase of metformin T max with a 40% augmentation of the AUC/D value.

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Dissolution test for site-specific release isoniazid pellets in USP apparatus 3 (reciprocating cylinder): Optimization using response surface methodology

Cited by 41 publications

References 12 publications

Comparison of Three Dissolution Apparatuses for Testing Calcium Phosphate Pellets used as Ibuprofen Delivery Systems

Comparison of Three Dissolution Apparatuses for Testing Calcium Phosphate Pellets used as Ibuprofen Delivery Systems

Melt-in-Mouth Multi-particulate System for the Treatment of ADHD: A Convenient Platform for Pediatric Use

Improving Oral Bioavailability and Pharmacokinetics of Liposomal Metformin by Glycerolphosphate–Chitosan Microcomplexation

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