A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms.

abstract：:The objective of the study was to develop a mathematical model for predicting the disintegration time of fast disintegrating tablets (FDTs) by estimating the powder characteristics of powder blend prior to compression. A combination of chitosan-alginate complex and glycine in the ratio of 50:50 was used for preparing ...

journal_title：Pharmaceutical development and technology

authors： Goel H,Arora A,Tiwary AK,Rana V

更新日期：2011-02-01 00:00:00

abstract：:The objective of this investigation was to formulate ocular inserts of gatifloxacin sesquehydrate to achieve controlled drug release. Drug reservoir was prepared using hydrophilic polymers, namely polyvinyl alcohol and polyvinyl pyrrolidone. The rate controlling membrane was prepared using hydrophobic ethyl cellulose ...

journal_title：Pharmaceutical development and technology

authors： Patel UL,Chotai NP,Nagda CD

更新日期：2012-01-01 00:00:00

abstract：:The objective of this study was to investigate the effect of the physiological parameters (pH, buffer capacity, and ionic strength) of the gastrointestinal (GI) fluid on the dissolution behavior of the class II weakly acidic (BCS class IIa) drug valsartan. A series of in vitro dissolution studies was carried out on Di...

journal_title：Pharmaceutical development and technology

authors： Hamed R

更新日期：2018-12-01 00:00:00

abstract：:The purpose of this study was to assess the impact of impurities in formulation components, antioxidants, formulation pH, and processing/packaging on the extent of color change associated with oxidation of danofloxacin injectable. The methods used in this study include reversed-phase HPLC, UV-VIS spectrophotometry, at...

journal_title：Pharmaceutical development and technology

authors： Kasraian K,Kuzniar AA,Wilson GG,Wood JA

更新日期：1999-01-01 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 prepare various types of solid dispersions (SDs) by the hot-melt extrusion technique. Next, process analytical technology (PAT) such as Fourier transform-infrared (FT-IR) and Raman and near infrared (NIR) spectroscopy were applied to determine the solubilization effect. The SDs and its tab...

journal_title：Pharmaceutical development and technology

authors： Hwang I,Renuka V,Lee JH,Weon KY,Kang CY,Lee BJ,Park JB

更新日期：2020-06-01 00:00:00

abstract：:The objectives of this research were to evaluate the stability of lercanidipine in solution state and solid state and explore the compatibility of drug with oils, surfactants and cosurfactants as excipients. The effect of pH on the degradation in solution state was studied through pH-rate profile of lercanidipine in c...

journal_title：Pharmaceutical development and technology

authors： Parmar N,Amin S,Singla N,Kohli K

更新日期：2012-11-01 00:00:00

abstract：:Bupivacaine lipid microparticles were prepared and evaluated as a parenteral sustained-release dosage form for postoperative pain management. Bupivacaine free base was incorporated into a molten tristearin matrix and lipid micro-particles were subsequently formed from this molten mixture by a spray-congealing process....

journal_title：Pharmaceutical development and technology

authors： Li LC,Zhu L,Song JF,Deng JS,Bandopadhyay R,Wurster DE

更新日期：2005-01-01 00:00:00

abstract：:The instability of protein and antigen(s) during encapsulation in biodegradable polymers by water-in-oil-in-water (w/o/w) encapsulation is well established. The aim of present study is to screen various additives to prevent the inactivation and loss of immunogenicity of HBsAg upon its exposure to the water/CH(2)Cl(2) ...

journal_title：Pharmaceutical development and technology

authors： Tomar P,Giri N,Karwasara VS,Pandey RS,Dixit VK

更新日期：2012-07-01 00:00:00

abstract：:Ranitidine tablets USP showed variable intra- and inter-lab dissolution results. In order to ascertain the reason for this behavior, ranitidine tablets USP produced by (BIPI) Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, and Zantac Tablets (brand of ranitidine USP), Glaxo Inc., Research Triangle, NC, were...

journal_title：Pharmaceutical development and technology

authors： Cappola ML

更新日期：2001-01-01 00:00:00

abstract：:The hygroscopicity of Brequinar sodium, an organ transplant immunosuppressant, at 75% relative humidity highly depends on the crystal form or crystallinity of the drug substance. Hygroscopicity and ease of water uptake of three lots of Brequinar sodium were investigated. Those lots contained different impurities at le...

journal_title：Pharmaceutical development and technology

authors： Wu LS,Pang J,Hussain MA

更新日期：1996-04-01 00:00:00

abstract：:Alendronate sodium (ALD) is a bisphosphonate medication used in the treatment and prevention of osteoporosis. Absorption of ALD as oral formulation is very poor (0.5%-1%). Its bioavailability can decrease with food effect. It has some gastrointestinal adverse effects such as gastritis, gastric ulcer, and esophagitis. ...

journal_title：Pharmaceutical development and technology

authors： Asikoğlu M,Ozguney I,Ozcan I,Orumlu O,Guneri T,Koseoğlu K,Ozkilic H

更新日期：2008-01-01 00:00:00

abstract：:Transdermal drug administration has a number of advantages that cannot be leveraged for therapeutic benefits because of the robust barrier provided by the stratum corneum. One of the promising techniques for circumventing the stratum corneum is sonophoresis - the use of ultrasound for facilitating transdermal drug del...

journal_title：Pharmaceutical development and technology

authors： Ita K

更新日期：2017-06-01 00:00:00

abstract：:The aim of the present study is to prepare risperidone-loaded poly lactic-co-glycolic acid (PLGA) microspheres within microfluidic system and to achieve a formulation with uniform size and monotonic and reproducible release profile. In comparison to batch method, T-junction and serpentine chips were utilized and optim...

journal_title：Pharmaceutical development and technology

authors： Jafarifar E,Hajialyani M,Akbari M,Rahimi M,Shokoohinia Y,Fattahi A

更新日期：2017-09-01 00:00:00

abstract：:Starches obtained from four different Dioscorea species namely White (D. rotundata), Bitter (D. dumetorum), Chinese (D. oppositifolia) and Water yam (D. alata), were modified by acid hydrolysis and the physicochemical, material and tablet formation properties of the starches were investigated with the aim of determini...

journal_title：Pharmaceutical development and technology

authors： Odeku OA,Picker-Freyer KM

更新日期：2009-01-01 00:00:00

abstract：:A paddle method for measurement of the disintegrating time of orally disintegrating tablets with rizatriptan benzoate as a model drug was evaluated. The paddle method employed a dissolution test assembly with tablets immersed in disintegrating medium through a fastened sinker. Paddle stirring rate, opening of the sink...

journal_title：Pharmaceutical development and technology

authors： Que L,Wu W,Cheng X,Hu T

更新日期：2006-01-01 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：:New microspheres containing hydrophilic core and hydrophobic coating as a controlled-release system with no toxic reagents were proposed. Water in oil in water (W/O/W) emulsion and solvent evaporation methods were used to make chitosan/ cellulose acetate (CCA) microspheres sized 200 - 400 microm. Ranitidine hydrochlor...

journal_title：Pharmaceutical development and technology

authors： Zhou HY,Chen XG,Liu CS,Meng XH,Yu LJ,Liu XY,Liu N

更新日期：2005-01-01 00:00:00

abstract：:To improve the solubility and bioavailability of oridonin (ORI), glycerol monooleate lipid (GMO)- or phytantriol (PYT)-Poloxamer 407-propylene glycol-water systems were firstly used to develop cubosomes containing ORI for oral delivery. These cubosomes prepared through the fragmentation of bulk gels under homogenizati...

journal_title：Pharmaceutical development and technology

authors： Shi X,Peng T,Huang Y,Mei L,Gu Y,Huang J,Han K,Li G,Hu C,Pan X,Wu C

更新日期：2017-05-01 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：: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：:A prototype parenteral manufacturing facility based on isolation technology was designed, constructed, and commissioned at Warner-Lambert Co., Morris Plains, NJ, with emphasis on its application to research and development (R&D) settings. The facility contains closed isolators for holding, transferring, and manufactur...

journal_title：Pharmaceutical development and technology

authors： Krishna AK,Lodhi SA,Harris MR

更新日期：2000-01-01 00:00:00

abstract：:In recent years, drug delivery systems such as liposomes and microparticles have been used in clinic for the treatment of different diseases and from a regulatory point of view, a parenterally applied drug and drug delivery systems must be sterile and pyrogen free. Radiation sterilization is a method recognized by pha...

journal_title：Pharmaceutical development and technology

authors： Sakar F,Özer AY,Erdogan S,Ekizoglu M,Kart D,Özalp M,Colak S,Zencir Y

更新日期：2017-09-01 00:00:00

abstract：:The general solubility equation (GSE) is the state-of-the-art method for estimating the aqueous solubilities of organic compounds. It is an extremely simple equation that expresses aqueous solubility as a function of only two inputs: the octanol-water partition coefficient calculated by readily available softwares lik...

journal_title：Pharmaceutical development and technology

authors： Alantary D,Yalkowsky S

更新日期：2018-09-01 00:00:00

abstract：:The investigation was aimed at developing thermodynamically stable topical delivery system of nanostructured lipid carrier of econazole nitrate (EN) for the treatment of deep seated fungal infection by improving its permeability. Fifteen formulations (F1-F15) of nanostructured lipid carriers (NLCs) were prepared by so...

journal_title：Pharmaceutical development and technology

authors： Keshri L,Pathak K

更新日期：2013-05-01 00:00:00

abstract：CONTEXT:Freeze-drying in presence of excipients is a common practice to stabilize biomacromolecular formulations. The composition of this formulation is known to affect the quality of the final product. OBJECTIVE:The aim of this study was to evaluate freeze-drying in well-plates as a high throughput platform for formu...

journal_title：Pharmaceutical development and technology

authors： Trnka H,Rantanen J,Grohganz H

更新日期：2015-01-01 00:00:00

abstract：:The objective of this study was to prepare pellets of thyme (Thymus vulgaris L.), stinging nettle (Urtica dioica L.) and sage (Salvia officinalis L.) dry extracts by extrusion-spheronization technique to improve technological properties and investigate dissolution profiles of pellets covered different levels of pH-sen...

journal_title：Pharmaceutical development and technology

authors： Kaledaite R,Bernatoniene J,Dvořáčková K,Gajdziok J,Muselík J,Pečiūra R,Masteikova R

更新日期：2015-11-01 00:00:00

abstract：:Novel fast-disintegrating multi-unit tablets (FDMUTs) were prepared to modify the release of lornoxicam (a potent non-steroidal anti-inflammatory drug with a short half-life) as well as to combine the advantages of multi-unit systems with the cost-effectiveness of compressed tablets. The proposed FDMUTs consisted of s...

journal_title：Pharmaceutical development and technology

authors： Aburahma MH,Hamza Yel-S

更新日期：2011-08-01 00:00:00

abstract：:Background: Clindamycin's bitter taste and odor is known to affect treatment adherence in children. Recently, a formulation of clindamycin HCl complexed with ion exchange resin IRP 69 was shown to mask the bitter taste. Because of the potential benefit of this formulation for children, a pilot study using a porcine mo...

journal_title：Pharmaceutical development and technology

authors： Goode GA,Wagh SJ,Irby DJ,Ma D,Jacobs RF,Kearns GL,Almoazen H

更新日期：2019-10-01 00:00:00

abstract：:In this study, the degradation of Octastatin, a cyclic octapeptide analog of somatostatin, was examined as a function of pH, temperature, buffer, and ionic strength by reversed-phase gradient high-performance liquid chromatography. Degradation of Octastatin followed a first-order kinetics. Various buffer species such ...

journal_title：Pharmaceutical development and technology

authors： Jang SW,Woo BH,Lee JT,Moon SC,Lee KC,DeLuca PP

更新日期：1997-11-01 00:00:00