Abstract：
:The purpose of this study was to improve the sensitivity and accuracy of quantitative analysis of polymorphic mixtures. Various techniques such as hand grinding and mixing (in mortar and pestle), air jet milling and ball milling for micronization of particle and mixing were used to prepare binary mixtures. Using these techniques, mixtures of form I and form II of clopidogrel bisulphate were prepared in various proportions from 0-5% w/w of form I in form II and subjected to x-ray powder diffraction analysis. In order to obtain good resolution in minimum time, step time and step size were varied to optimize scan rate. Among the six combinations, step size of 0.05 degrees with step time of 5 s demonstrated identification of maximum characteristic peaks of form I in form II. Data obtained from samples prepared using both grinding and mixing in ball mill showed good analytical sensitivity and accuracy compared to other methods. Powder x-ray diffraction method was reproducible, precise with LOD of 0.29% and LOQ of 0.91%. Validation results showed excellent correlation between actual and predicted concentration with R2 > 0.9999.
journal_name
Pharm Dev Technoljournal_title
Pharmaceutical development and technologyauthors
Alam S,Patel S,Bansal AKdoi
10.3109/10837450903286511subject
Has Abstractpub_date
2010-09-01 00:00:00pages
452-9issue
5eissn
1083-7450issn
1097-9867journal_volume
15pub_type
杂志文章abstract：INTRODUCTION:Theoretical models of the freeze-drying process are potentially useful to guide the design of a freeze-drying process as well as to obtain information not readily accessible by direct experimentation, such as moisture distribution and glass transition temperature, Tg, within a vial during processing. Previ...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.1081/pdt-35869
更新日期：2005-01-01 00:00:00
abstract：:The present study was aimed to optimize capsulated unfolding type gastroretentive bilayer film constituting immediate release (IR) layer of amlodipine besylate and sustained release (SR) layer of atorvastatin calcium. A three-factor, three-level Box-Behnken-design was used to optimize bilayer film with dual-release ch...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.1080/10837450.2019.1705486
更新日期：2020-04-01 00:00:00
abstract：:Mechanically generated radicals were shown to affect short-term stability of a model pharmaceutical formulation during high-shear processing. A formulation containing an oxidatively sensitive drug, either amorphous or crystalline, and a polymeric excipient was high-shear mixed and the resulting short-term degradation ...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.1080/10837450802328869
更新日期：2008-01-01 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
pub_type： 杂志文章
doi：10.3109/10837450.2012.663390
更新日期：2013-05-01 00:00:00
abstract：:Mucosa has now been recognized as a potential site for both local and systemic delivery of therapeutics. Mucoadhesive drug delivery systems with customizable release profiles have recently gained considerable interest among formulation scientists to improve clinical outcomes of drugs. This review summarizes the curren...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.1080/10837450.2020.1753771
更新日期：2020-09-01 00:00:00
abstract：:The physicochemical properties and enzymatic stability of esters of phenylephrone, synthesized on the basis of the chemical delivery system (CDS) concept, were studied as a new class of mydriatic agents. Potentiometrically determined ionization constants (pKa) of the novel compounds were in the range 7.19-7.21. The th...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.1081/pdt-100101353
更新日期：1999-05-01 00:00:00
abstract：:Owing to its limited aqueous solubility, Phytomenadione (vitamin K) undergoes a low bioavailability (50%) with a large inter-individual variability after oral administration. Therefore, the aim of this work was to incorporate vitamin K into nanostructure lipid carrier systems to improve its aqueous solubility and bioa...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.1080/10837450.2017.1312440
更新日期：2018-04-01 00:00:00
abstract：:The contact time of a vehicle on the cornea is of utmost importance for ophthalmic drug delivery. The poor bioavailability and therefore poor therapeutic response exhibited by the conventional ophthalmic solutions due to pre-corneal elimination of a drug may be overcome by the use of the in situ gel forming systems, w...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.3109/10837450903262033
更新日期：2010-07-01 00:00:00
abstract：:In the pharmaceutical industry, chemometrics is rapidly establishing itself as a tool that can be used at every step of product development and beyond: from early development to commercialization. This set of multivariate analysis methods allows the extraction of information contained in large, complex data sets thus ...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章,评审
doi：10.3109/10837450.2014.898656
更新日期：2015-01-01 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
pub_type： 杂志文章
doi：10.1080/10837450.2018.1536996
更新日期：2018-12-01 00:00:00
abstract：:The compendial method of evaluation of orodispersible tablets (ODT) is the same disintegration test as for conventional tablets. Since it does not reflect the disintegration process in the oral cavity, alternative methods are proposed that are more related to in vivo conditions, e.g. modified dissolution paddle appara...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.3109/10837450.2012.710238
更新日期：2013-03-01 00:00:00
abstract：:The effect of six factors: spray gun, formulation, inlet temperature, atomizing air pressure, fan air pressure, and gun-bed distance, on the final adhesion of the film coat to the tablet core were assessed. The method used was based on an experimental design, Resolution IV, that allowed the main effects to be free fro...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.1081/pdt-49692
更新日期：2005-01-01 00:00:00
abstract：:The main purpose of this work was to study the albendazole-cyclodextrins complexation equilibrium and to propose a suitable excipient to improve the solubility behavior and dissolution rate of albendazole. The complexation of albendazole with four cyclodextrins, alpha-CD, beta-CD, gamma-CD, and hydroxypropylated (HP)-...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.3109/10837459809009867
更新日期：1998-08-01 00:00:00
abstract：:This study reports on the impact of cyclodextrin addition on the phase behavior of microemulsion systems. Three distinct oil-in-water microemulsions were formulated and subjected to increasing concentrations of various cyclodextrins. The prepared formulations underwent visual, textural and microscopic characterization...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.1080/10837450.2017.1371191
更新日期：2018-02-01 00:00:00
abstract：:The biopharmaceutical assessment of new drug candidates based on their chemical structure is important in drug discovery and development. The scope of this study is to focus on lipophilic drugs and to clarify the role of their chemical predictors on oral bioavailability in humans. First their chemical properties were ...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.1080/10837450802626296
更新日期：2009-01-01 00:00:00
abstract：:The purpose of this research was to design and develop a novel controlled-release bead formulation for oral administration with buffer crystals as a carrier for loading of fenoldopam mesylate, an intravenous antihypertensive agent, which provides an in vitro release rate of 30-50 mg/hr for 6-8 hr. Buffer crystals were...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.3109/10837459809028629
更新日期：1998-11-01 00:00:00
abstract：:Oily liquid drugs are not convenient for oral administration. We developed a powder containing clofibrate (CF), a model of an oily drug, using aminoalkyl methacrylate copolymer (EPO) or methacrylic acid copolymer (L100). CF or a mixture of CF and soybean oil was emulsified with EPO or L100 aqueous solution. Using a hi...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.3109/10837450.2015.1086370
更新日期：2016-12-01 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
pub_type： 杂志文章
doi：10.3109/10837450.2015.1135342
更新日期：2017-06-01 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
pub_type： 杂志文章
doi：10.1080/10837450.2017.1321663
更新日期：2018-09-01 00:00:00
abstract：:Objective: A polymer-based nanoparticle was constructed to target sorafenib delivery to colorectal carcinoma cells and decrease the side effects of the drug.Methods: Sorafenib-loaded nanoparticles (S-NPs) based on PEG-PLGA were prepared using a double emulsion solvent evaporation method. The properties of S-NPs were e...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.1080/10837450.2020.1718704
更新日期：2020-06-01 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
pub_type： 杂志文章
doi：10.3109/10837450.2016.1163393
更新日期：2017-09-01 00:00:00
abstract：:The aim of the present work was the development of vaginal sponge-like dressings based on chitosan ascorbate (CS) and on hyaluronic acid sodium salt/lysine acetate (HAS) combination. Sponge-like dressings were prepared by freeze-drying and characterized for mechanical resistance and mucoadhesion. CS dressings show hig...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.3109/10837450.2010.531736
更新日期：2012-03-01 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
pub_type： 杂志文章
doi：10.1080/10837450.2016.1238484
更新日期：2018-12-01 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
pub_type： 杂志文章
doi：10.1080/10837450802409388
更新日期：2009-01-01 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
pub_type： 杂志文章
doi：10.1080/10837450701702941
更新日期：2008-01-01 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
pub_type： 杂志文章
doi：10.3109/10837450.2012.659256
更新日期：2013-05-01 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
pub_type： 杂志文章
doi：10.1080/10837450.2018.1425433
更新日期：2019-01-01 00:00:00
abstract：:A high-pressure homogenization method for the production of aqueous suspensions of poly(D,L-lactide) and poly(D,L-lactide-co-glycolide) was investigated. Depending on the production conditions it was possible to produce micro--as well as nanoparticulate systems without the use of organic solvents. The influence of dif...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.3109/10837459809009857
更新日期：1998-08-01 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
pub_type： 杂志文章
doi：10.3109/10837450903055494
更新日期：2010-03-01 00:00:00
abstract：:The physical-chemical processing variables affecting particle size following precipitation using the supercritical antisolvent (SAS) method were investigated by varying both the composition of the feed solvent and the structure of the solute, using a series of steroids. The key factor influencing particle size in thes...
journal_title：Pharmaceutical development and technology
pub_type： 杂志文章
doi：10.1080/10837450600561299
更新日期：2006-01-01 00:00:00
