Multivariate analysis in the pharmaceutical industry: enabling process understanding and improvement in the PAT and QbD era.

abstract：:An approach for cancer treatment is modulation of tumor microenvironment. Based on the role of extracellular matrix in cell modulation, fabrication of textured materials mimicking extracellular matrix could provide novel opportunities such as determining cancer cell behaviour. With this background, in this work, we ha...

journal_title：Pharmaceutical development and technology

authors： Yaşayan G,Mega Tiber P,Orun O,Alarçin E

更新日期：2020-12-01 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：:Several processing and shipping stresses were investigated for their effect on the physical stability of recombinant human growth hormone (rhGH). These included exposure to air/water interfaces, adsorption to hydrophobic surfaces, freeze-thaw cycles, and temperature. The interfacially and thermally denatured hormone w...

journal_title：Pharmaceutical development and technology

authors： Katakam M,Banga AK

更新日期：1997-05-01 00:00:00

abstract：:Purpose: Intestinal drug absorption is one of the main factors that govern the fraction of oral dose absorbed (Fa) of drugs. It is reported that oral absorption of bortezomib (BTZ) can be restricted by its low intestinal permeability. In this study, we aimed to evaluate the impact of self-nanoemulsifying drug delivery...

journal_title：Pharmaceutical development and technology

authors： Mahmoudian M,Valizadeh H,Löbenberg R,Zakeri-Milani P

更新日期：2020-03-01 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：:The dry coating process was evaluated in terms of storage stability investigating drug release and agglomeration tendency of the different coated oral dosage forms; hydroxypropyl methylcellulose acetate succinate (HPMCAS) was used with triethylcitrate (TEC) as plasticizer and acetylated monoglyceride (Myvacet) as wett...

journal_title：Pharmaceutical development and technology

authors： Kablitz CD,Urbanetz NA

更新日期：2009-01-01 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：: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

authors： Sacha GA,Schmitt WJ,Nail SL

更新日期：2006-01-01 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：: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 object of this study was to enhance the solubility, dissolution rate, and oral bioavailability of rutin by complexation with 2-hydroxypropyl-beta-cyclodextrin (HP-beta-CyD). The interaction of rutin with cyclodextrins (CyDs) was evaluated by the solubility, and ultraviolet (UV) and circular dichroism (CD) spectrop...

journal_title：Pharmaceutical development and technology

authors： Miyake K,Arima H,Hirayama F,Yamamoto M,Horikawa T,Sumiyoshi H,Noda S,Uekama K

更新日期：2000-01-01 00:00:00

abstract：:Microporous polymeric matrices prepared from poly(ɛ-caprolactone) [PCL] were evaluated for controlled vaginal delivery of the antiprotozoal agent (tinidazole) in the treatment of the sexually transmitted infection, trichomoniasis. The matrices were produced by rapidly cooling co-solutions of PCL and tinidazole in acet...

journal_title：Pharmaceutical development and technology

authors： Fernando HV,Chan LL,Dang N,Santhanes D,Banneheke H,Nalliah S,Coombes AGA

更新日期：2019-03-01 00:00:00

abstract：:The purpose of this study was to develop a method to prepare Metoprolol Succinate (MS) sustained release pellets and compress them into pellet-containing tablets without losing sustained release property. The drug layered pellets were coated with Eudragit NE 30D to obtain a sustained release (SR) property. The mechani...

journal_title：Pharmaceutical development and technology

authors： Yang Z,Yu J,Yang T,Xing H,Zhang J,Xian L,Ding P,Wang D

更新日期：2016-12-01 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：: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：: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：:This paper explores the utility of aqueous solubility of structurally similar drugs in predicting optimum conditions for extrusion and spheronization of pellets using response surface methodology. Pharmacologically active xanthine derivatives exhibiting widely varying aqueous solubility were used to determine optimum ...

journal_title：Pharmaceutical development and technology

authors： Hileman GA,Upadrashta SM,Neau SH

更新日期：1997-02-01 00:00:00

abstract：:In the current study, the influence of chitosan on the dissolution rate and bioavailability of acyclovir has been illustrated through the preparation of co-crystals by simple solvent change method. Chitosan was precipitated on acyclovir crystals using sodium citrate as the salting out agent. The pure drug and the prep...

journal_title：Pharmaceutical development and technology

authors： Allam AN,Naggar VF,El Gamal SS

更新日期：2013-07-01 00:00:00

abstract：:Dissolution profiles of various multiparticulate controlled-release dosage forms prepared by applying lipophilic materials using a hot-melt coating technique were analyzed to determine release kinetics. The dosage forms were prepared using a novel solid dispersion hot-melt fluid bed coating method. Various lipophilic ...

journal_title：Pharmaceutical development and technology

authors： Griffin EN,Niebergall PJ

更新日期：1999-01-01 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：:Hypericin (Hyp), a natural hydrophobic and photoactive pigment, and methylene blue (MB), a hydrophilic cationic dye, are utilized as photosensitizer (PS) for photodynamic therapy of cancer. Bioadhesive and thermoresponsive polymeric systems can improve the drug availability by increasing the contact time between the s...

journal_title：Pharmaceutical development and technology

authors： Borghi-Pangoni FB,Junqueira MV,Bruschi ML

更新日期：2020-04-01 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 purpose of this research was to prepare various injectable, protein (cytochrome c)-loaded biodegradable poly(lactide-co-glycolide) (PLGA) devices by a novel microencapsulation method and to compare their characteristics. Syringeable mixtures of polymer and protein solidified upon injection when coming in contact w...

journal_title：Pharmaceutical development and technology

authors： Jain RA,Rhodes CT,Railkar AM,Malick AW,Shah NH

更新日期：2000-01-01 00:00:00

abstract：:The effect of chemical enhancers (e.g., fatty acids, limonene, depilatory lotions) and iontophoresis was investigated on the in vitro permeability of leuprolide acetate through porcine epidermis. Franz diffusion cells and Scepter iontophoretic power source were used for the percutaneous absorption studies. Anodal iont...

journal_title：Pharmaceutical development and technology

authors： Rastogi SK,Singh J

更新日期：2004-11-01 00:00:00

abstract：:Quality by design (QbD) is an essential part of the modern approach to pharmaceutical quality. This study was conducted in the framework of a QbD project involving ramipril tablets. Preliminary work included identification of the critical quality attributes (CQAs) and critical process parameters (CPPs) based on the qu...

journal_title：Pharmaceutical development and technology

authors： Aksu B,Paradkar A,de Matas M,Özer Ö,Güneri T,York P

更新日期：2013-02-01 00:00:00

abstract：:The purpose of this study was to develop a benchtop apparatus to simulate the scale-up of the moist-heat sterilization process of sodium carboxymethylcellulose (CMC) gel and identify critical process parameters that affect the sterilized gel viscosity. A 600-ml benchtop Parr reactor was modified and used to achieve go...

journal_title：Pharmaceutical development and technology

authors： Chu PI,Doyle D

更新日期：1999-01-01 00:00:00

abstract：BACKGROUND:Oxaliplatin has long been used for the treatment of colorectal cancer via intra-venous infusion. In order to improve patient compliance, a solid dosage form for oral administration of oxaliplatin was prepared as nano-sized particles. METHOD:Nano oxaliplatin was prepared employing Fat Employing Supercritical...

journal_title：Pharmaceutical development and technology

authors： Lee SJ,Kim YH,Lee SH,Hahn M

更新日期：2012-03-01 00:00:00

abstract：:The interaction of 5-nitro-2-furfurilylidene benzhydrazide (5NFB), potential anti-trypanosomal compound, with micellar solutions was studied. The results indicated that 50 mug of 5NFB completely kills 20 million T. cruzi epimastigote cells within 3 days, whereas the same amount of benznidazole kills 30% of the cells a...

journal_title：Pharmaceutical development and technology

authors： Rangel-Yagui CO,Hsu HW,Barbosa LR,Caetano W,Pessoa A Jr,Tavares LC,Itri R

更新日期：2007-01-01 00:00:00

abstract：CONTEXT AND OBJECTIVE:The objective of the study was to develop a stable capsule formulation of ziprasidone hydrochloride which can be administered without regards to food intake. MATERIALS AND METHODS:The unstable anhydrous form of ziprasidone hydrochloride was stabilized employing hot-melt extrusion and further opti...

journal_title：Pharmaceutical development and technology

authors： Banerjee S,Shankar KR,Prasad Y R

更新日期：2016-11-01 00:00:00

abstract：:Letrozole (LTZ), an aromatase inhibitor used for the treatment of hormonally-positive breast cancer in postmenopausal women, has poor water solubility, rapid metabolism, and a range of side effects. In this study, polymer-based nanoparticles (NPs) incorporating the drug have been designed and characterized, aimed to c...

journal_title：Pharmaceutical development and technology

authors： Alemrayat B,Elhissi A,Younes HM

更新日期：2019-02-01 00:00:00