About the equivalence between different batches of a glycopeptide drug.

abstract：CONTEXT:The recent US Food and Drug Administration (FDA) legislation has introduced the evaluation of the Design Space of critical process parameters in manufacturing processes. In freeze-drying, a "formulation" is expected to be robust when minor deviations of the product temperature do not negatively affect the final...

journal_title：Pharmaceutical development and technology

authors： Schneid SC,Stärtzel PM,Lettner P,Gieseler H

更新日期：2011-11-01 00:00:00

abstract：:The aim of this study was to develop and characterize nanocrystal formulation containing nimesulide. Physical mixture of drug and excipient (nimesulide:pluronic F127, 1:0.5) was also prepared to compare the efficiency of formulations. The physicochemical characteristics of the formulations were determined by means of ...

journal_title：Pharmaceutical development and technology

authors： Gülsün T,Budak C,Vural I,Sahin S,Öner L

更新日期：2013-05-01 00:00:00

abstract：:An anomalous peak was observed in the HPLC/UV analysis of a developmental drug product. High resolution LC/MS revealed that the mass of this degradant was 12 Da greater than the drug substance, corresponding to a net gain of a single carbon atom. The degradant was reproduced by incubating the drug substance with forma...

journal_title：Pharmaceutical development and technology

authors： Zhong Q,Stowers S,Segraves NL,Ngim KK,Zhang K,Bostick T,Deese A,Chetwyn NP

更新日期：2013-07-01 00:00:00

abstract：:Our previous study reported that the Design Expert® Software showed a beneficial role in the development of microemulsions (ME) for transdermal drug delivery. To fully confirm the reproducibility and the reliability of simultaneous optimal ME formulations, the optimal ME formulations predicted by the Design Expert® So...

journal_title：Pharmaceutical development and technology

authors： Duangjit S,Chairat W,Opanasopit P,Rojanarata T,Ngawhirunpat T

更新日期：2016-09-01 00:00:00

abstract：:The main objective of this research is to use the near-infrared diffuse reflectance method to evaluate and quantify the effects of hardness and porosity on the near-infrared spectras of tablets. To develop a model equation, validate the model and test the model predictive ability. Seven theophylline tablet formulation...

journal_title：Pharmaceutical development and technology

authors： Donoso M,Kildsig DO,Ghaly ES

更新日期：2003-01-01 00:00:00

abstract：:Two types of casein hydrolysates, casein A (mean peptide length 3.3) and casein B (mean peptide length 17.4) were prepared by the enzymatic hydrolysis of casein, and their effects on in vitro dissolution rates and oral bioavailability of drugs were evaluated. The in vitro dissolution behavior of the kneaded mixture of...

journal_title：Pharmaceutical development and technology

authors： Imai T,Nishiyama T,Shameem M,Otagiri M

更新日期：1998-05-01 00:00:00

abstract：:There is as yet no commercialized preparation for oral administration of flecainide acetate (FA) to children. In such cases, manipulation of commercial tablets is the usual practice in pharmacy services of hospitals and compounding pharmacies, to provide a suitable dosage form for this vulnerable pediatric population ...

journal_title：Pharmaceutical development and technology

authors： Santoveña A,Charola I,Suárez-González J,Teigell-Pérez N,García-van Nood S,Soriano M,Fariña JB

更新日期：2018-12-01 00:00:00

abstract：:The objective of the present work is to investigate the presence or absence of a critical concentration of maize starch according to the percolation theory for a truly ternary system with respect to a minimum disintegration time. The results of this study show that the application of percolation theory is not limited ...

journal_title：Pharmaceutical development and technology

authors： Kimura G,Puchkov M,Betz G,Leuenberger H

更新日期：2007-01-01 00:00:00

abstract：:Effects of various factors, such as light intensity, polarizability of n-alcohol solvents, addition of colorants, and viscosity of solutions on the kinetics of the photoisomerization of therapeutically effective E-isomer of sorivudine to its less effective Z-isomer were studied. Solutions of known concentrations of E-...

journal_title：Pharmaceutical development and technology

authors： Desai D,Li D,Janjikhel R,Lang B,Jain N

更新日期：2001-01-01 00:00:00

abstract：:In the present study, Simvastatin was incorporated in emulsion of soybean oil and propylene glycol monocaprylate as oily phase and Tween 80 and Cremophor EL as surfactants and also their mixtures. Dry adsorbed emulsions were prepared by using colloidal silicon dioxide in varying proportions to adsorb the liquid emulsi...

journal_title：Pharmaceutical development and technology

authors： Dixit RP,Nagarsenker MS

更新日期：2007-01-01 00:00:00

abstract：:A preliminary study of the feasibility of using near-infrared spectroscopy (NIRS) for the offline simultaneous determination of metoprolol tartrate (MTP) and hydrochlorothiazide (HTZ) in powders and tablets has been carried out. An industrial tableting process was simulated using an instrumented tablet press replicato...

journal_title：Pharmaceutical development and technology

authors： Vranic BZ,Vandamme TF

更新日期：2015-01-01 00:00:00

abstract：:Magnesium stearate (MgSt) is a widely used pharmaceutical lubricant in tablet manufacturing. However, batch-to-batch variability in hydrate form and surface area can lead to inconsistency in tablet performance. In this work, several unique MgSt samples were studied: traditional monohydrate samples with high surface ar...

journal_title：Pharmaceutical development and technology

authors： Calahan JL,Paul S,Yanez EG,DeNeve D,Sun CC,Munson EJ

更新日期：2021-02-01 00:00:00

abstract：:A novel analytical procedure has been developed for quantitative determination of levodopa and carbidopa in aqueous binary solutions acidified by HCl and without any other sample pretreatment. The method is based partially on least squares treatment of data obtained by attenuated total reflectance Fourier transform in...

journal_title：Pharmaceutical development and technology

authors： Khanmohammadi M,Mobedi E,Garmarudi AB,Mobedi H,Kargosha K

更新日期：2007-01-01 00:00:00

abstract：:Drug solubility testing in biorelevant media has become an indispensable tool in pharmaceutical development. Despite this importance, there is still an incomplete understanding of how poorly soluble compounds interact with these media. The aim of this study was to apply the concept of the apparent solubilization capac...

journal_title：Pharmaceutical development and technology

authors： Schwebel HJ,van Hoogevest P,Leigh ML,Kuentz M

更新日期：2011-06-01 00:00:00

abstract：:The aim of this study was to investigate isotropic mono- and diglyceride-based (MCMDG) systems, which are potential vehicles for injectable products containing both hydrophilic and lipophilic drugs. For two-component systems, MCMDG was mixed with various masses of water. For three-component systems, the samples were p...

journal_title：Pharmaceutical development and technology

authors： Sari P,Razzak M,Tucker IG

更新日期：2004-01-01 00:00:00

abstract：:This paper assesses the cause of particulate formation in vials of the experimental antitumor agent bisnafide and investigates pharmaceutical techniques to reduce the number of particulates in the product. Solution preparation and particulate isolation were performed under Class 100 laminar air flow. Reversed-phase HP...

journal_title：Pharmaceutical development and technology

authors： Rubino JT,Chan LL,Walker JT,Segretario J,Everlof JG,Hussain MA

更新日期：1999-08-01 00:00:00

abstract：:Vardenafil hydrochloride (VAR) is an erectile dysfunction treating drug. VAR has a short elimination half-life (4-5 h) and suffers low oral bioavailability (15%). This work aimed to explore the dual potential of VAR-dendrimer complexes as drug release modulators and oral bioavailability enhancers. VAR-dendrimer comple...

journal_title：Pharmaceutical development and technology

authors： Tawfik MA,Tadros MI,Mohamed MI

更新日期：2019-03-01 00:00:00

abstract：:The present study details the development of a small-scale spray-drying approach for the routine screening of amorphous solid dispersions (ASDs). This strategy aims to overcome the limitations of standard screening methodologies like solvent casting and quench cooling to predict drug-polymer miscibility of spray-dried...

journal_title：Pharmaceutical development and technology

authors： Ousset A,Bassand C,Chavez PF,Meeus J,Robin F,Schubert MA,Somville P,Dodou K

更新日期：2019-06-01 00:00:00

abstract：PURPOSE:To investigate the influence of the pH of the dissolution medium on immediate release 850 mg metformin hydrochloride tablets. METHODS:A traditional wet granulation method was used to manufacture metformin hydrochloride tablets with or without a disintegrant. Tablet dissolution was conducted using the USP appar...

journal_title：Pharmaceutical development and technology

authors： Desai D,Wong B,Huang Y,Tang D,Hemenway J,Paruchuri S,Guo H,Hsieh D,Timmins P

更新日期：2015-01-01 00:00:00

abstract：:Nucleic acids therapeutic efficiency is generally limited by their low stability and intracellular bioavailability, and by the toxicity of the carriers used to deliver them to the target sites. Aminated poly(glycerol methacrylate) polymers are biodegradable and pH-sensitive polymers that have been used previously to d...

journal_title：Pharmaceutical development and technology

authors： Morsi NG,Ali SM,Elsonbaty SS,Afifi AA,Hamad MA,Gao H,Elsabahy M

更新日期：2018-04-01 00:00:00

abstract：:Novel buccal adhesive system (NBAS) containing Nimodipine (N) was prepared and evaluated by different parameters such as weight uniformity, thickness, hardness, surface pH, swelling index, mucoadhesive strength (MS), in vitro drug release and ex vivo drug permeation. Different formulations containing 5-20% Carbopol 93...

journal_title：Pharmaceutical development and technology

authors： Hassan N,Ali M,Ali J

更新日期：2010-03-01 00:00:00

abstract：:In this study, we designed a polymersome system for the controlled release of methotrexate (MTX) as an anticancer drug with the objective of improving the loading efficiency of the drug in polymersomes as well as achievement of an efficient control on the release rate of drug from nanocarriers. We synthesized mono met...

journal_title：Pharmaceutical development and technology

authors： Nosrati H,Adinehvand R,Manjili HK,Rostamizadeh K,Danafar H

更新日期：2019-01-01 00:00:00

abstract：:Taking into account possible irritation of the skin upon contact with naproxen (NPX) crystals and lower bioavailability after administration of the suspended or ionized drug, the aim of the work was to design and characterize novel and easy-to-formulate gels with the entirely dissolved drug in the acidic form. The for...

journal_title：Pharmaceutical development and technology

authors： Osmałek T,Milanowski B,Froelich A,Górska S,Białas W,Szybowicz M,Kapela M

更新日期：2017-06-01 00:00:00

abstract：:The formulation of betamethasone-17-valerate (BV) into topical medicines presents a significant challenge for the formulation chemist. The substance is susceptible to acid and base catalyzed isomerization in aqueous environments, which results in valerate transesterification from carbon 17 to carbon 21 of the steroid ...

journal_title：Pharmaceutical development and technology

authors： Byrne J,Wyraz A,Velasco-Torrijos T,Reinhardt R

更新日期：2017-06-01 00:00:00

abstract：:Aqueous concentrated plain mixtures of dextran and concanavalin A (con A) were examined for their rheological response to glucose for comparison with previously studied partially photopolymerized acrylic derivatives. Non-destructive oscillatory tests were undertaken within the linear viscoelastic range to examine the ...

journal_title：Pharmaceutical development and technology

authors： Taylor MJ,Tanna S,Sahota TS

更新日期：2010-01-01 00:00:00

abstract：:To develop an effective therapeutic treatment, the potential of poly (lactic-co-glycolic acid)-polyethylene glycol-retinoic acid (PLGA-PEG-RA) polymeric micelles for targeted delivery of irinotecan to hepatocellular carcinoma (HepG2) and colorectal cancer cell lines (HT-29) was evaluated. PLGA-PEG-RA was synthesized b...

journal_title：Pharmaceutical development and technology

authors： Emami J,Maghzi P,Hasanzadeh F,Sadeghi H,Mirian M,Rostami M

更新日期：2018-01-01 00:00:00

abstract：:Supercritical fluid extraction (SFE), with carbon dioxide as the solvent, was tested for its ability to remove common reactive impurities from several pharmaceutical excipient powders including starch, microcrystalline cellulose (MCC), hydroxypropylcellulose (HPC), polyethylene oxide (PEO), and polyvinylpyrrolidone (P...

journal_title：Pharmaceutical development and technology

authors： Ashraf-Khorassani M,Taylor LT,Waterman KC,Narayan P,Brannegan DR,Reid GL

更新日期：2005-01-01 00:00:00

abstract：:We have proposed a theory indicating the correlation between the dissolution rate and the heat of solution of drug substances. The initial dissolution rates of the drug substances containing amorphous were predicted accurately from their heats of solution. In this report, the possibility for the theory to estimate the...

journal_title：Pharmaceutical development and technology

authors： Yoshihashi Y,Yonemochi E,Terada K

更新日期：2002-01-01 00:00:00

abstract：:Mefenamic acid (MA), a poorly water-soluble drug, was used as a model substance to investigate granules and tablet characteristics to be optimized for the loading volume of MA (0-74.1% v/v) in the formulation including lactose monohydrate/maize starch (7/3) as excipients. The compactibility of granules increased with ...

journal_title：Pharmaceutical development and technology

authors： Kimura G,Betz G,Leuenberger H

更新日期：2008-01-01 00:00:00

abstract：:Seven potential impurities, including by-products, starting materials and intermediates were identified in pharmaceutical substance quetiapine fumarate and characterized by spectroscopic methods (MS, IR, NMR). Based on these methods the structures of the impurities were assigned or confirmed as: impurity I: 2-(phenylt...

journal_title：Pharmaceutical development and technology

authors： Stolarczyk EU,Kaczmarek L,Eksanow K,Kubiszewski M,Glice M,Kutner A

更新日期：2009-01-01 00:00:00