Assessment Methodology for Process Validation Lifecycle Stage 3A.

abstract：:The present work explores inner structuration of in situ gelling system consisting of glyceryl monooleate (GMO) and oleic acid (OA). The system under study involves investigation of microstructural changes which are believed to govern the pharmaceutical performance of final formulation. The changes which are often ter...

journal_title：AAPS PharmSciTech

authors： Patil SS,Venugopal E,Bhat S,Mahadik KR,Paradkar AR

更新日期：2015-10-01 00:00:00

abstract：:The aim of this work was to assess the effect of 2 formulation variables, the pectin type (with different degrees of esterification [DEs]) and the amount of calcium, on drug release from pectin-based matrix tablets. Pectin matrix tablets were prepared by blending indomethacin (a model drug), pectin powder, and various...

journal_title：AAPS PharmSciTech

authors： Sungthongjeen S,Sriamornsak P,Pitaksuteepong T,Somsiri A,Puttipipatkhachorn S

更新日期：2004-02-12 00:00:00

abstract：:A hydroxyethylcellulose-poly(acrylic acid) (HEC-PAA) lyomatrix was developed for ganciclovir (GCV) intestine targeting to overcome its undesirable degradation in the stomach. GCV was encapsulated within the HEC-PAA lyomatrix prepared by lyophilization. Conventional tablets were also prepared with identical GCV concent...

journal_title：AAPS PharmSciTech

authors： Mabrouk M,Mulla JA,Kumar P,Chejara DR,Badhe RV,Choonara YE,du Toit LC,Pillay V

更新日期：2016-10-01 00:00:00

abstract：:The aim of this study was to prepare bi-layer tablet of Metoclopramide Hydrochloride (MTH) and Ibuprofen (IB) for the effective treatment of migraine. MTH and IB were formulated as immediate and sustained release layer respectively. MTH was formulated as immediate release layer by using various disintegrants like Ac-D...

journal_title：AAPS PharmSciTech

authors： Shiyani B,Gattani S,Surana S

更新日期：2008-01-01 00:00:00

abstract：:This work combines several methods in an integrated strategy to develop a matrix for buccal administration. For this purpose, tablets containing selected mucoadhesive polymers loaded with a model drug (omeprazole), free or in a complexed form with cyclodextrins, and in the absence and presence of alkali agents were su...

journal_title：AAPS PharmSciTech

authors： Figueiras A,Pais AA,Veiga FJ

更新日期：2010-12-01 00:00:00

abstract：:Present investigation deals with formulation and evaluation of tamoxifen (TMX)-loaded liquid crystalline nanoparticles (TMX-LCNPs) for improving oral bioavailability and safety of the existing treatment. Hexagonal Glyceryl monooleate-based TMX-LCNPs (GLCNPs) and Phytantriol-based TMX-LCNPs (PLCNPs) were prepared by di...

journal_title：AAPS PharmSciTech

authors： Jain S,Heeralal B,Swami R,Swarnakar NK,Kushwah V

更新日期：2018-01-01 00:00:00

abstract：:We determined the permeability coefficient of a model hydrophilic drug, calcein, encapsulated within saturated lipid-based nano-sized liposomes of various lipid profiles. We demonstrated that the addition of cholesterol to liposomes containing saturated lipids increased the permeability of the liposomal membrane to ca...

journal_title：AAPS PharmSciTech

authors： Takechi-Haraya Y,Sakai-Kato K,Goda Y

更新日期：2017-07-01 00:00:00

abstract：:The purpose of this study was to develop formulations and systematically evaluate in vitro performances of buccoadhesive patches of propranolol hydrochloride using the hydrophobic polymer Eudragit L-100 as the base matrix. The hydrophilic polymers Carbopol 934 and polyvinyl pyrrolidone (PVP) K30 were incorporated into...

journal_title：AAPS PharmSciTech

authors： Patel VM,Prajapati BG,Patel MM

更新日期：2007-06-22 00:00:00

abstract：:The present study was designed to test the hypothesis that programmed cell death-1 (PD-1) siRNA can downregulate PD-1 expression in macrophages in culture and in tumor tissues in mice and inhibit tumor growth in a mouse model. PD-1 siRNA was encapsulated in solid lipid nanoparticles (SLNs), and the physical properties...

journal_title：AAPS PharmSciTech

authors： Hanafy MS,Hufnagel S,Trementozzi AN,Sakran W,Stachowiak JC,Koleng JJ,Cui Z

更新日期：2021-01-31 00:00:00

abstract：:Topical administration is a preferable choice for local anesthetic delivery. Microemulsions have shown great effectiveness for transdermal transport of lidocaine. However, fabrication of microemulsions containing highly concentrated lidocaine (10%) to provide an extended local anesthetic effect is still a challenge. T...

journal_title：AAPS PharmSciTech

authors： Wang Y,Wang X,Wang X,Song Y,Wang X,Hao J

更新日期：2019-01-09 00:00:00

abstract：:A folic acid-conjugated paclitaxel (PTX)-doxorubicin (DOX)-loaded nanostructured lipid carrier(s) (FA-PTX-DOX NLCs) were prepared by using emulsion-evaporation method and extensively characterized for particle size, polydispersity index, zeta potential, and % entrapment efficiency which were found to be 196 ± 2.5 nm, ...

journal_title：AAPS PharmSciTech

authors： Raikwar S,Vyas S,Sharma R,Mody N,Dubey S,Vyas SP

更新日期：2018-11-01 00:00:00

abstract：:The purpose of this research was to use inline real-time near-infrared (NIR) to measure the moisture content of granules manufactured using a commercial production scale continuous twin-screw granulator fluid-bed dryer milling process. A central composite response surface statistical design was used to study the effec...

journal_title：AAPS PharmSciTech

authors： Chablani L,Taylor MK,Mehrotra A,Rameas P,Stagner WC

更新日期：2011-12-01 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：:The present study was aimed to optimize, develop, and evaluate microemulsion and microemulsion-based gel as a vehicle for transungual drug delivery of terbinafine hydrochloride for the treatment of onychomycosis. D-optimal mixture experimental design was adopted to optimize the composition of microemulsion having amou...

journal_title：AAPS PharmSciTech

authors： Thatai P,Sapra B

更新日期：2017-08-01 00:00:00

abstract：:Non-invasive administration of insulin is expected for better diabetes mellitus therapy. In this report, we developed intraoral preparation for insulin. Insulin was encapsulated into nanocarrier using self-assembly emulsification process. To increase lipophilicity of insulin, it was dispersed in phospholipid resulted ...

journal_title：AAPS PharmSciTech

authors： Rachmawati H,Haryadi BM,Anggadiredja K,Suendo V

更新日期：2015-06-01 00:00:00

abstract：:To ensure consistency of clinical outcomes, orally inhaled therapies must exhibit consistent delivered dose and aerosol properties at the time of manufacturing, throughout storage, and during various patient-use conditions. Achieving consistency across these scenarios has presented a significant challenge, especially ...

journal_title：AAPS PharmSciTech

authors： Doty A,Schroeder J,Vang K,Sommerville M,Taylor M,Flynn B,Lechuga-Ballesteros D,Mack P

更新日期：2018-02-01 00:00:00

abstract：:A target product profile (TPP) describes how a product will be utilized by the end user. A systematically developed TPP can ensure alignment of objectives across company departments, accelerate development timelines, minimize development risks, and eventually lead to an optimal product. A TPP is particularly important...

journal_title：AAPS PharmSciTech

authors： Lambert WJ

更新日期：2010-09-01 00:00:00

abstract：:The purpose of the present study was to design mucoadhesive gliadin nanoparticles (GNP) containing amoxicillin and to evaluate their effectiveness in eradicating Helicobacter pylori. GNP-bearing amoxicillin (AGNP) was prepared by desolvation method. The effect of process variables such as gliadin concentration and ini...

journal_title：AAPS PharmSciTech

authors： Umamaheshwari RB,Ramteke S,Jain NK

更新日期：2004-04-07 00:00:00

abstract：:Kinetic methods for accurate determination of nortriptyline hydrochloride have been described. The methods are based on the oxidation of nortriptyline hydrochloride with KMnO4 in acidic and basic media. In acidic medium, the decrease in absorbance at 525.5 nm and in basic medium, the increase in absorbance at 608.5 nm...

journal_title：AAPS PharmSciTech

authors： Rahman N,Khan S

更新日期：2015-06-01 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：:Pellet manufacturing by extrusion/spheronization is quite common in the pharmaceutical field because the obtained product is characterized by a high sphericity as well as a narrow particle size distribution. The established mechanisms only consider deformation of the initially fractured particles but do not account fo...

journal_title：AAPS PharmSciTech

authors： Koester M,Thommes M

更新日期：2010-12-01 00:00:00

abstract：:Poly(vinyl alcohol) (PVA)-based formulations are used for pharmaceutical tablet coating with numerous advantages. Our objective is to study the stability of PVA-based coating films in the presence of acidic additives, alkaline additives, and various common impurities typically found in tablet formulations. Opadry® II ...

journal_title：AAPS PharmSciTech

authors： Koo OM,Fiske JD,Yang H,Nikfar F,Thakur A,Scheer B,Adams ML

更新日期：2011-06-01 00:00:00

abstract：:For the prediction of the air and product temperatures, the product moisture, and the air humidity during a coating process in a Bohle Lab-Coater, a model was developed. The purpose of this work was to determine the limit moisture, the critical moisture, and the constant for the exchange rate between both zones and to...

journal_title：AAPS PharmSciTech

authors： Page S,Baumann KH,Kleinebudde P

更新日期：2006-05-05 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：:Individualized medicines for pediatrics are a useful alternative if there is no correct dosage marketed for this segment (easy to swallow, adequate volume and content, correct composition for pediatrics, good organoleptic properties, etc.). Its validation process must ensure quality testing: its content uniformity, ph...

journal_title：AAPS PharmSciTech

authors： Suárez-González J,Santoveña-Estévez A,Armijo-Ruíz S,Castillo A,Fariña JB

更新日期：2019-06-03 00:00:00

abstract：:While the concept of using polymer-based sustained-release delivery systems to maintain therapeutic concentration of protein drugs for extended periods of time has been well accepted for decades, there has not been a single product in this category successfully commercialized to date despite clinical and market demand...

journal_title：AAPS PharmSciTech

authors： Wu F,Jin T

更新日期：2008-01-01 00:00:00

abstract：:The ability to produce submicron particles of monoclonal antibodies of different sizes and shapes would enhance their application to pulmonary delivery. Although non-ionic surfactants are widely used as stabilizers in protein formulations, we hypothesized that non-ionic surfactants will affect the shape and size of su...

journal_title：AAPS PharmSciTech

authors： Srinivasan AR,Shoyele SA

更新日期：2013-03-01 00:00:00

abstract：:Incorporation of drug-loaded nanoparticles into swellable and respirable microparticles is a promising strategy to avoid rapid clearance from the lung and achieve sustained drug release. In this investigation, a copolymer of polyethylene glycol grafted onto phthaloyl chitosan (PEG-g-PHCs) was synthesized and then self...

journal_title：AAPS PharmSciTech

authors： Du J,El-Sherbiny IM,Smyth HD

更新日期：2014-12-01 00:00:00

abstract：:The aim of this study was to compare the densification of powder mixtures on eccentric and rotary tablet presses and to establish relationships with the halving properties of the resulting scored tablets. This is an important problem because the recent guidelines of EU require verification of the equal masses of table...

journal_title：AAPS PharmSciTech

authors： Sovány T,Kása P Jr,Pintye-Hódi K

更新日期：2009-01-01 00:00:00

abstract：:The purpose of this research was to explore the possibility of employing PAT for particle sizing during spray drying with the use of an in-line and at-line laser diffraction system. Microspheres were made using maltodextrin and modified starch as wall material and size results obtained using PAT compared with those de...

journal_title：AAPS PharmSciTech

authors： Chan LW,Tan LH,Heng PW

更新日期：2008-01-01 00:00:00