The Experts below are selected from a list of 324 Experts worldwide ranked by ideXlab platform
Angela D Moore - One of the best experts on this subject based on the ideXlab platform.
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influence of hydroxypropyl methylcellulose mixture apparent viscosity and Tablet Hardness on drug release using a 23 full factorial design
Drug Development and Industrial Pharmacy, 2002Co-Authors: Kavita H Khanvilkar, Ye Huang, Angela D MooreAbstract:ABSTRACTThis study investigates the effects of three factors: (1) use of a mixture of two different grades of hydroxypropyl methylcellulose (HPMC), (2) apparent viscosity, and (3) Tablet Hardness on drug release profiles of extended-release matrix Tablets. The lot-to-lot apparent viscosity difference of HPMC K15M on in vitro dissolution was also investigated. Four test formulations were made, each containing 10% of a very water-soluble active pharmaceutical ingredient (API), 32% HPMC K15M, or a mixture of HPMC K100LV and HPMC K100M, 56% diluents, and 2% lubricants. Each formulation was made at two Hardness levels. A 23 full factorial design was used to study various combinations of the three factors using eight experiments conducted in a randomized order. Dissolution studies were performed in USP apparatus I. The values of t50% (time in which 50% drug is released) and tlag (lag time, the time taken by the matrix Tablet edges to get hydrated and achieve a state of quasi-equilibrium before erosion and the a...
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influence of hydroxypropyl methylcellulose mixture apparent viscosity and Tablet Hardness on drug release using a 2 3 full factorial design
Drug Development and Industrial Pharmacy, 2002Co-Authors: Kavita H Khanvilkar, Ye Huang, Angela D MooreAbstract:ABSTRACTThis study investigates the effects of three factors: (1) use of a mixture of two different grades of hydroxypropyl methylcellulose (HPMC), (2) apparent viscosity, and (3) Tablet Hardness on drug release profiles of extended-release matrix Tablets. The lot-to-lot apparent viscosity difference of HPMC K15M on in vitro dissolution was also investigated. Four test formulations were made, each containing 10% of a very water-soluble active pharmaceutical ingredient (API), 32% HPMC K15M, or a mixture of HPMC K100LV and HPMC K100M, 56% diluents, and 2% lubricants. Each formulation was made at two Hardness levels. A 23 full factorial design was used to study various combinations of the three factors using eight experiments conducted in a randomized order. Dissolution studies were performed in USP apparatus I. The values of t50% (time in which 50% drug is released) and tlag (lag time, the time taken by the matrix Tablet edges to get hydrated and achieve a state of quasi-equilibrium before erosion and the a...
Manel Alcala - One of the best experts on this subject based on the ideXlab platform.
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a process analytical technology approach based on near infrared spectroscopy Tablet Hardness content uniformity and dissolution test measurements of intact Tablets
Journal of Pharmaceutical Sciences, 2006Co-Authors: Marcelo Blanco, Manel Alcala, Josep M Gonzalez, Ester TorrasAbstract:Abstract Near infrared spectroscopy (NIRS) is a nondestructive analytical technique that enables simultaneous measurements of chemical composition ( viz. the content in active pharmaceutical ingredient, API) and various physical properties ( viz. Tablet Hardness and dissolution profile) in pharmaceutical Tablets. In this work, partial least squares (PLS) calibration models and discriminant partial least squares (DPLS) classification models were constructed by using calibration sets consisting of laboratory samples alone. The laboratory samples were mixtures of the API and excipients that were pressed into Tablets. API content, Tablet Hardness, and dissolution measurements of intact Tablets were made by using three different calibration models that are fast—results can be obtained within a few seconds—, simple and robust—they involve minimal analyst intervention—, and clean—they use no toxic reagent and produce no toxic waste. Based on the results, the proposed NIR method is an effective alternative to current reference methods for the intended purpose. The advantages provided by NIR spectroscopy in this context confirm its potential for inclusion in process analytical technologies in the pharmaceutical industry.
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content uniformity and Tablet Hardness testing of intact pharmaceutical Tablets by near infrared spectroscopy a contribution to process analytical technologies
Analytica Chimica Acta, 2006Co-Authors: Marcelo Blanco, Manel AlcalaAbstract:Abstract The use of process analytical technologies by the pharmaceutical industry is a response to its growing need for improved productivity in order to face the increasing competition in this field. In this work, we explored the use of near infrared spectroscopy (NIRS) for the determination of physical (Tablet Hardness) and chemical parameters (active principle and content uniformity) in intact individual pharmaceutical Tablets. Quantization was done by using a Partial Least Squares 1 (PLS1) calibration model constructed from laboratory calibration samples that were prepared by mixing the active principle and excipients, and pressing the mixture into Tablets. The compaction pressure to be applied to the powder was previously determined by using another PLS1 model that allows calculating it from production Tablets. The NIRS method used to quantify the active principle is simpler as the calibration set encompasses the variability sources present in production samples; also, it allows individual Tablets to be analysed. The proposed method was validated in accordance with the International Conference on Harmonization (ICH) and The European Agency for the Evaluation of Medicinal Products (EMEA) guidelines, and found to be fit for its intended purpose.
Amal Elkordy - One of the best experts on this subject based on the ideXlab platform.
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design and evaluation of effervescent floating Tablets based on hydroxyethyl cellulose and sodium alginate using pentoxifylline as a model drug
Drug Design Development and Therapy, 2015Co-Authors: Safwan Abdel Rahim, Paul Carter, Amal ElkordyAbstract:The aim of this work was to design and evaluate effervescent floating gastro-retentive drug delivery matrix Tablets with sustained-release behavior using a binary mixture of hydroxyethyl cellulose and sodium alginate. Pentoxifylline was used as a highly water-soluble, short half-life model drug with a high density. The floating capacity, swelling, and drug release behaviors of drug-loaded matrix Tablets were evaluated in 0.1 N HCl (pH 1.2) at 37°C±0.5°C. Release data were analyzed by fitting the power law model of Korsmeyer–Peppas. The effect of different formulation variables was investigated, such as wet granulation, sodium bicarbonate gas-forming agent level, and Tablet Hardness properties. Statistical analysis was applied by paired sample t-test and one-way analysis of variance depending on the type of data to determine significant effect of different parameters. All prepared Tablets through wet granulation showed acceptable physicochemical properties and their drug release profiles followed non-Fickian diffusion. They could float on the surface of dissolution medium and sustain drug release over 24 hours. Tablets prepared with 20% w/w sodium bicarbonate at 50–54 N Hardness were promising with respect to their floating lag time, floating duration, swelling ability, and sustained drug release profile.
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effects of liquisolid formulations on dissolution of naproxen
European Journal of Pharmaceutics and Biopharmaceutics, 2009Co-Authors: Ngiik Tiong, Amal ElkordyAbstract:Abstract The aim of this study was to investigate the use of liquisolid technique in improving the dissolution profiles of naproxen in a solid dosage form. This study was designed to evaluate the effects of different formulation variables, i.e. type of non-volatile liquid vehicles and drug concentrations, on drug dissolution rates. The liquisolid Tablets were formulated with three different liquid vehicles, namely Cremophor ® EL (polyoxyl 35 castor oil), Synperonic ® PE/L61 (poloxamer 181, polyoxyethylene–polyoxypropylene copolymer) and poly ethylene glycol 400 (PEG400) at two drug concentrations, 20%w/w and 40%w/w. Avicel ® PH102 was used as a carrier material, Cab-o-sil ® M-5 as a coating material and maize starch as a disintegrant. The empirical method as introduced by Spireas and Bolton (1999) [1] was applied strictly to calculate the amounts of coating and carrier materials required to prepare naproxen liquisolid Tablets. Quality control tests, i.e. uniformity of Tablet weight, uniformity of drug content, Tablet Hardness, friability test, disintegration and dissolution tests were performed to evaluate each batch of prepared Tablets. In vitro drug dissolution profiles of the liquisolid formulations were studied and compared with conventional formulation, in simulated gastric fluid (pH 1.2) and simulated intestinal fluid (pH 7.2) without enzyme. Stability studies were carried out to evaluate the stability of the Tablets under humid conditions. Differential scanning calorimetry and Fourier transform infrared were used to investigate physicochemical interaction between naproxen and the excipients. It was found that liquisolid Tablets formulated with Cremophor ® EL at drug concentration of 20%w/w produced high dissolution profile with acceptable Tablet properties. The stability studies showed that the dissolution profiles of liquisolid Tablets prepared with Cremophor ® EL were not affected by ageing significantly. Furthermore, DSC revealed that drug particles in liquisolid formulations were completely solubilised.
Marcelo Blanco - One of the best experts on this subject based on the ideXlab platform.
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a process analytical technology approach based on near infrared spectroscopy Tablet Hardness content uniformity and dissolution test measurements of intact Tablets
Journal of Pharmaceutical Sciences, 2006Co-Authors: Marcelo Blanco, Manel Alcala, Josep M Gonzalez, Ester TorrasAbstract:Abstract Near infrared spectroscopy (NIRS) is a nondestructive analytical technique that enables simultaneous measurements of chemical composition ( viz. the content in active pharmaceutical ingredient, API) and various physical properties ( viz. Tablet Hardness and dissolution profile) in pharmaceutical Tablets. In this work, partial least squares (PLS) calibration models and discriminant partial least squares (DPLS) classification models were constructed by using calibration sets consisting of laboratory samples alone. The laboratory samples were mixtures of the API and excipients that were pressed into Tablets. API content, Tablet Hardness, and dissolution measurements of intact Tablets were made by using three different calibration models that are fast—results can be obtained within a few seconds—, simple and robust—they involve minimal analyst intervention—, and clean—they use no toxic reagent and produce no toxic waste. Based on the results, the proposed NIR method is an effective alternative to current reference methods for the intended purpose. The advantages provided by NIR spectroscopy in this context confirm its potential for inclusion in process analytical technologies in the pharmaceutical industry.
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content uniformity and Tablet Hardness testing of intact pharmaceutical Tablets by near infrared spectroscopy a contribution to process analytical technologies
Analytica Chimica Acta, 2006Co-Authors: Marcelo Blanco, Manel AlcalaAbstract:Abstract The use of process analytical technologies by the pharmaceutical industry is a response to its growing need for improved productivity in order to face the increasing competition in this field. In this work, we explored the use of near infrared spectroscopy (NIRS) for the determination of physical (Tablet Hardness) and chemical parameters (active principle and content uniformity) in intact individual pharmaceutical Tablets. Quantization was done by using a Partial Least Squares 1 (PLS1) calibration model constructed from laboratory calibration samples that were prepared by mixing the active principle and excipients, and pressing the mixture into Tablets. The compaction pressure to be applied to the powder was previously determined by using another PLS1 model that allows calculating it from production Tablets. The NIRS method used to quantify the active principle is simpler as the calibration set encompasses the variability sources present in production samples; also, it allows individual Tablets to be analysed. The proposed method was validated in accordance with the International Conference on Harmonization (ICH) and The European Agency for the Evaluation of Medicinal Products (EMEA) guidelines, and found to be fit for its intended purpose.
Kavita H Khanvilkar - One of the best experts on this subject based on the ideXlab platform.
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influence of hydroxypropyl methylcellulose mixture apparent viscosity and Tablet Hardness on drug release using a 23 full factorial design
Drug Development and Industrial Pharmacy, 2002Co-Authors: Kavita H Khanvilkar, Ye Huang, Angela D MooreAbstract:ABSTRACTThis study investigates the effects of three factors: (1) use of a mixture of two different grades of hydroxypropyl methylcellulose (HPMC), (2) apparent viscosity, and (3) Tablet Hardness on drug release profiles of extended-release matrix Tablets. The lot-to-lot apparent viscosity difference of HPMC K15M on in vitro dissolution was also investigated. Four test formulations were made, each containing 10% of a very water-soluble active pharmaceutical ingredient (API), 32% HPMC K15M, or a mixture of HPMC K100LV and HPMC K100M, 56% diluents, and 2% lubricants. Each formulation was made at two Hardness levels. A 23 full factorial design was used to study various combinations of the three factors using eight experiments conducted in a randomized order. Dissolution studies were performed in USP apparatus I. The values of t50% (time in which 50% drug is released) and tlag (lag time, the time taken by the matrix Tablet edges to get hydrated and achieve a state of quasi-equilibrium before erosion and the a...
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influence of hydroxypropyl methylcellulose mixture apparent viscosity and Tablet Hardness on drug release using a 2 3 full factorial design
Drug Development and Industrial Pharmacy, 2002Co-Authors: Kavita H Khanvilkar, Ye Huang, Angela D MooreAbstract:ABSTRACTThis study investigates the effects of three factors: (1) use of a mixture of two different grades of hydroxypropyl methylcellulose (HPMC), (2) apparent viscosity, and (3) Tablet Hardness on drug release profiles of extended-release matrix Tablets. The lot-to-lot apparent viscosity difference of HPMC K15M on in vitro dissolution was also investigated. Four test formulations were made, each containing 10% of a very water-soluble active pharmaceutical ingredient (API), 32% HPMC K15M, or a mixture of HPMC K100LV and HPMC K100M, 56% diluents, and 2% lubricants. Each formulation was made at two Hardness levels. A 23 full factorial design was used to study various combinations of the three factors using eight experiments conducted in a randomized order. Dissolution studies were performed in USP apparatus I. The values of t50% (time in which 50% drug is released) and tlag (lag time, the time taken by the matrix Tablet edges to get hydrated and achieve a state of quasi-equilibrium before erosion and the a...
