Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use.

abstract：:Nanoemulsions are increasingly being investigated for their fascinating capability of loading both hydrophobic and hydrophilic molecules while their stability is still an issue, being affected by various factors. In this study, to evaluate the dominant factors affecting the stability of nanoemulsions, artificial neura...

journal_title：AAPS PharmSciTech

authors： Ahmadi Lakalayeh G,Faridi-Majidi R,Saber R,Partoazar A,Mehr SE,Amani A

更新日期：2012-12-01 00:00:00

abstract：:The effects of electron beam or gamma-irradiation on technological performances (capsule hardness, expressed as deforming work and dissolution time) of empty 2-shell capsules made of gelatin or hydroxypropylmethylcellulose (HPMC) were studied. Capsule structural changes induced by radiation treatment were investigated...

journal_title：AAPS PharmSciTech

authors： Cilurzo F,Selmin F,Minghetti P,Montanari L,Lenardi C,Orsini F,Poletti G

更新日期：2005-12-01 00:00:00

abstract：:The objective of the present study is to investigate the confounding effects, if any, of beta-cyclodextrins (βCDs) on corneal permeability coefficients obtained from in vitro transmembrane diffusion studies. Transcorneal permeability studies were carried out with 2-hydroxypropyl-beta-cyclodextrin (HPβCD) and randomly ...

journal_title：AAPS PharmSciTech

authors： Adelli GR,Balguri SP,Majumdar S

更新日期：2015-10-01 00:00:00

abstract：:The development of an oral formulation that ensures increased bioavailability of drugs is a great challenge for pharmaceutical scientists. Among many oral formulation systems, a drug delivery system employing superporous networks was developed to provide a prolonged gastro-retention time as well as improved bioavailab...

journal_title：AAPS PharmSciTech

authors： Le TN,Her J,Sim T,Jung CE,Kang JK,Oh KT

更新日期：2020-11-12 00:00:00

abstract：:The airways are verified as a relevant route to improve antibody therapeutic index with superior lung concentration but limited passage into systemic blood stream. The current research aimed to process spray-dried (SD) powder of Infliximab to assess the feasibility of respiratory delivery of antibody for local suppres...

journal_title：AAPS PharmSciTech

authors： Faghihi H,Najafabadi AR,Daman Z,Ghasemian E,Montazeri H,Vatanara A

更新日期：2019-02-26 00:00:00

abstract：:The objective of this study was to produce microparticles of a new asthma-controlling drug by supercritical assisted atomization (SAA), proposed as an alternative to conventional jet-milling process. SAA is based on the solubilization of supercritical carbon dioxide in a liquid solution containing the drug; the ternar...

journal_title：AAPS PharmSciTech

authors： Della Porta G,De Vittori C,Reverchon E

更新日期：2005-10-22 00:00:00

abstract：:This study examined the mechanical (hardness, compressibility, adhesiveness, and cohesiveness) and rheological (zero-rate viscosity and thixotropy) properties of polyethylene glycol (PEG) gels that contain different ratios of Carbopol 934P (CP) and polyvinylpyrrolidone K90 (PVP). Mechanical properties were examined us...

journal_title：AAPS PharmSciTech

authors： Tan YT,Peh KK,Al-Hanbali O

更新日期：2000-08-17 00:00:00

abstract：:The purpose of this study was to develop a lyotropic liquid crystalline formulation using the emulsifier vitamin E TPGS and evaluate its behavior after incorporation of a flavonoid, quercetin. The physical (macro and microscopic), chemical (determination of quercetin content by the HPLC method) and functional (determi...

journal_title：AAPS PharmSciTech

authors： Vicentini FT,Casagrande R,Verri WA Jr,Georgetti SR,Bentley MV,Fonseca MJ

更新日期：2008-01-01 00:00:00

abstract：:Chemical penetration enhancers (CPEs) are frequently incorporated into transdermal delivery systems (TDSs) to improve drug delivery and to reduce the required drug load in formulations. However, the minimum detectable effect of formulation changes to CPE-containing TDSs using in vitro permeation tests (IVPT), a widely...

journal_title：AAPS PharmSciTech

authors： Shin SH,Srivilai J,Ibrahim SA,Strasinger C,Hammell DC,Hassan HE,Stinchcomb AL

更新日期：2018-10-01 00:00:00

abstract：:This work examines the influence of various process parameters (like sodium alginate concentration, calcium chloride concentration, and hardening time) on papain entrapped in ionotropically cross-linked alginate beads for stability improvement and site-specific delivery to the small intestine using neural network mode...

journal_title：AAPS PharmSciTech

authors： Sankalia MG,Mashru RC,Sankalia JM,Sutariya VB

更新日期：2005-09-30 00:00:00

abstract：:Objective of the study was to design an injectable microsphere preparation with high drug loading of bupivacaine for prolonged release and local anesthetic. PLA or PLGA was used as the biodegradable matrix material to fabricate microspheres with the o/w emulsification-solvent evaporation method. The characterization o...

journal_title：AAPS PharmSciTech

authors： Xu J,Bai Y,Li X,Wei Z,Sun L,Yu H,Xu H

更新日期：2021-01-06 00:00:00

abstract：:The purpose of this article is to report final results of the evaluation of a chi-square ratio test proposed by the US Food and Drug Administration (FDA) for demonstrating equivalence of aerodynamic particle size distribution (APSD) profiles of nasal and orally inhaled drug products. A working group of the Product Qua...

journal_title：AAPS PharmSciTech

authors： Christopher D,Adams W,Amann A,Bertha C,Byron PR,Doub W,Dunbar C,Hauck W,Lyapustina S,Mitchell J,Morgan B,Nichols S,Pan Z,Singh GJ,Tougas T,Tsong Y,Wolff R,Wyka B

更新日期：2007-11-02 00:00:00

abstract：:The oxidation of glucagon by the H2O2/Cu(2+) system and by simulated sunlight was studied using HPLC-MS methodologies. It was found that copper ion-catalyzed oxidation is much faster in the residue 1-12 region than in photo-oxidation, but it is slower than photo-oxidation in the residue 18-29 region. This difference i...

journal_title：AAPS PharmSciTech

authors： Zhang J

更新日期：2016-08-01 00:00:00

abstract：:The exudates from the incised trunk of Terminalia randii has been evaluated as controlled release excipient in comparison with xanthan gum and hydroxypropylmethylcellulose (HPMC) using carvedilol (water insoluble) and theophylline (water soluble) as model drugs. Matrix tablets were prepared by direct compression and t...

journal_title：AAPS PharmSciTech

authors： Bamiro OA,Odeku OA,Sinha VR,Kumar R

更新日期：2012-03-01 00:00:00

abstract：:The objective of the present study was to develop fast dissolving oral film of the antipsychotic drug, flupentixol dihydrochloride, to enhance its bioavailability, optimize its therapeutic effect when used to treat depression with anxiety, and increase the convenience and compliance by the mentally ill, developmentall...

journal_title：AAPS PharmSciTech

authors： Abdelbary A,Bendas ER,Ramadan AA,Mostafa DA

更新日期：2014-12-01 00:00:00

abstract：:The purpose of this study was to compare the effects of denaturation by microwave irradiation on release properties of 2 physically different proteins. Matrices were prepared from water-soluble bovine serum albumin loaded with metoclopramide and sorbed with adequate amount of moisture were thermally denatured in a mic...

journal_title：AAPS PharmSciTech

authors： Qasem RJ

更新日期：2006-03-01 00:00:00

abstract：:A dissolution test for tablets containing 40 mg of olmesartan medoxomil (OLM) was developed and validated using both LC-UV and UV methods. After evaluation of the sink condition, dissolution medium, and stability of the drug, the method was validated using USP apparatus 2, 50 rpm rotation speed, and 900 ml of deaerate...

journal_title：AAPS PharmSciTech

authors： Bajerski L,Rossi RC,Dias CL,Bergold AM,Fröehlich PE

更新日期：2010-06-01 00:00:00

abstract：:Pneumocystis carinii pneumonia (PCP) is a major opportunistic infection that affects patients with human immunodeficiency virus. Although orally administered dapsone leads to high hepatic metabolism, decreasing the therapeutic index and causing severe side effects, this drug is an effective alternative for the treatme...

journal_title：AAPS PharmSciTech

authors： Ortiz M,Jornada DS,Pohlmann AR,Guterres SS

更新日期：2015-10-01 00:00:00

abstract：:The aim of this study was to investigate the influence of experimental conditions on levothyroxine sodium release from two immediate-release tablet formulations which narrowly passed the standard requirements for bioequivalence studies. The in vivo study was conducted as randomised, single-dose, two-way cross-over pha...

journal_title：AAPS PharmSciTech

authors： Kocic I,Homsek I,Dacevic M,Parojcic J,Miljkovic B

更新日期：2011-09-01 00:00:00

abstract：:In previous studies, we developed and characterised multicompartmental microcapsules as a platform for the targeted oral delivery of lipophilic drugs in type 2 diabetes (T2D). We also designed a new microencapsulated formulation of probucol-sodium alginate (PB-SA), with good structural properties and excipient compati...

journal_title：AAPS PharmSciTech

authors： Mooranian A,Negrulj R,Al-Sallami HS,Fang Z,Mikov M,Golocorbin-Kon S,Fakhoury M,Watts GF,Matthews V,Arfuso F,Lambros A,Al-Salami H

更新日期：2015-02-01 00:00:00

abstract：:The purpose of this research was to evaluate a novel fiber-optic photometer for its ability to monitor physical instabilities occurring in concentrated emulsions during storage. For this, the fiber-optic photometer was used to measure transmission of oil-in-water emulsions stabilized with hypromellose (HPMC) as a func...

journal_title：AAPS PharmSciTech

authors： Oliczewski S,Daniels R

更新日期：2007-08-31 00:00:00

abstract：:The objective of the current study was to develop an amorphous solid dispersion for a high melting point compound, griseofulvin (GRF), with an enhanced solubility and a controlled release pattern utilizing hot melt extrusion (HME) technology. Hypromellose acetate succinate (HPMCAS, Shin-Etsu AQOAT®, medium particle si...

journal_title：AAPS PharmSciTech

authors： Lu J,Obara S,Liu F,Fu W,Zhang W,Kikuchi S

更新日期：2018-01-01 00:00:00

abstract：:Piroxicam is used in the treatment of rheumatoid arthritis, osteoarthritis, and other inflammatory diseases. Upon oral administration, it is reported to cause ulcerative colitis, gastrointestinal irritation, edema and peptic ulcer. Hence, an alternative delivery system has been designed in the form of transethosome. T...

journal_title：AAPS PharmSciTech

authors： Garg V,Singh H,Bhatia A,Raza K,Singh SK,Singh B,Beg S

更新日期：2017-01-01 00:00:00

abstract：:The aims of the current study were to develop and evaluate clindamycin palmitate hydrochloride (CPH) 3D-printed tablets (printlets) manufactured by selective laser sintering (SLS). Optimization of the formulation was performed by studying the effect of formulation and process factors on critical quality attributes of ...

journal_title：AAPS PharmSciTech

authors： Mohamed EM,Barakh Ali SF,Rahman Z,Dharani S,Ozkan T,Kuttolamadom MA,Khan MA

更新日期：2020-08-13 00:00:00

abstract：:To enhance the stability of coenzyme Q10 (CoQ10), Kolliphor® HS 15 (HS15) was employed as a carrier to build up a stable CoQ10-loaded micelle delivery system. The impact of micellar compositions, the preparation condition, and the preparation method on size characteristics, the solubilization efficiency, and micellar ...

journal_title：AAPS PharmSciTech

authors： Liu L,Mao K,Wang W,Pan H,Wang F,Yang M,Liu H

更新日期：2016-06-01 00:00:00

abstract：:The objective of this work was the preparation of osmotic tablets using polymer blends of cellulose acetate butyrate (CAB) or ethylcellulose with ammonio methacrylate copolymer (Eudragit® RL). The advantage of these coatings in comparison to the traditionally used cellulose acetate is their solubility in safer organic...

journal_title：AAPS PharmSciTech

authors： Ali R,Walther M,Bodmeier R

更新日期：2018-01-01 00:00:00

abstract：:The scale up of production processes is a major challenge in pharmaceutical industry. Using a quality by design approach, upscaling can be based on the design space, which can be assessed on a small scale. In a previous study, the critical process parameters were identified by a definitive screening design on cetomacr...

journal_title：AAPS PharmSciTech

authors： van Heugten AJP,Vromans H

更新日期：2018-07-01 00:00:00

abstract：:Nanoparticles fabricated from the biodegradable and biocompatible polymer, polylactic-co-glycolic acid (PLGA), could be a promising system for targeting ocular drug delivery. The objective of this work was to investigate the possibility of encapsulating brinzolamide in PLGA nanoparticles in order to be applied as a su...

journal_title：AAPS PharmSciTech

authors： Salama HA,Ghorab M,Mahmoud AA,Abdel Hady M

更新日期：2017-10-01 00:00:00

abstract：:In this study, the resveratrol spray-dried emulsions were developed using a quality-by-design approach. Further, the product and process factors that affected the quality of the spray-dried emulsions were analyzed and illustrated using an Ishikawa diagram. The product and process risks were prioritized using a risk-ra...

journal_title：AAPS PharmSciTech

authors： Benjasirimongkol P,Piriyaprasarth S,Moribe K,Sriamornsak P

更新日期：2018-12-18 00:00:00

abstract：:The purpose of this research was to develop and evaluate buccal mucoadhesive controlled release tablets of lercanidipine hydrochloride using polyethylene oxide and different viscosity grades of hydroxypropyl methylcellulose individually and in combination. Effect of polymer type, proportion and combination was studied...

journal_title：AAPS PharmSciTech

authors： Charde S,Mudgal M,Kumar L,Saha R

更新日期：2008-01-01 00:00:00