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About 4,947 papers for “Dissolution testing”

Dissolution Testing

Aastha Sharma · 2025

Dissolution testing measures the rate and extent of drug release from pharmaceutical dosage forms. USP apparatus types 1-7 simulate in-vivo conditions with specific designs for various dosage forms, each requiring proper calibration and qualification. Method development considers media composition including pH, buffer capacity, and surfactants alongside hydrodynamic conditions, sampling strategies, and analytical finish methods. Immediate release, modified release, and poorly soluble drug formulations require tailored dissolution approaches. Data analysis applies model-dependent approaches using zero-order, first-order, and Higuchi equations alongside model-independent methods like dissolution efficiency and similarity factors. Mathematical modeling enables profile comparison and discrimination with statistical significance testing. Regulatory agencies establish method validation requirements, acceptance criteria, and specification setting practices globally. In vitro-in vivo correlation links dissolution behavior to pharmacokinetic parameters through levels A-C correlations, supporting biowaivers, formulation optimization, and specification setting.

Cited by 0Open access

Bayesian Dissolution Testing

Tony Pourmohamad, Robert C. Richardson · 2022

Dissolution studies are an integral part of pharmaceutical drug development, yet not much attention has been given in the way of Bayesian methods for dissolution testing. This chapter presents two Bayesian approaches to dissolution testing motivated by the well established f 2 statistic. Both methods are applied to a real dissolution data set from Ocaña et al. (2009) to show how Bayesian dissolution testing can be carried out. Custom R functions and code are provided for both methods for ease of use.

Cited by 0

Pharmaceutical Dissolution Testing

Umesh V. Banakar · 1991

Introduction, Historical Highlights, and the Need for Dissolution Testing Theories of Dissolution Dissolution Testing Devices Automation in Dissolution Testing, by William A. Hanson and Albertha M. Paul Factors That Influence Dissolution Testing Interpretation of Dissolution Rate Data Techniques and of In Vivo Dissolution, by Umesh V. Banakar, Chetan D. Lathia, and John H. Wood Dissolution of Dosage Forms Dissolution of Modified-Release Dosage Forms Dissolution and Bioavailability Dissolution Testing and the Assessment of Bioavailability/Bioequivalence, by Santosh J. Vetticaden Dissolution Rediscovered, by John H. Wood Appendix: USP/NF Dissolution Test.

Cited by 244

Dissolution-testing software

William M. Heller · American Journal of Health-System Pharmacy · 1987

Journal Article Dissolution-testing software Get access William M. Heller William M. Heller Search for other works by this author on: Oxford Academic Google Scholar American Journal of Hospital Pharmacy, Volume 44, Issue 10, 1 October 1987, Page 2367, https://doi.org/10.1093/ajhp/44.10.2367 Published: 01 October 1987

Cited by 0

Calorimetric dissolution testing.

Kazuhiko Iba, Emi Arakawa, Tommy C Morris et al. · Drug Development and Industrial Pharmacy · 1991

It is frequently desirable to obtain dissolution information about a new drug in the pre-formulation stage. This is difficult for two reasons. One is that there usually is not much drug available at this particular point in time (and e.g. a rotation disk dissolution (Levich, 1962) can hence, not be carried out). Another reason is that the assay methodology may not be completely worked out.The article to follow deals with the possibility of using calorimetry for this purpose. With a sensitive calorimeter it may be possible to determine dissolution characteristics at the hydrodynamics prevalent in the calorimeter, and then to correlate them with what happens in a USP dissolution apparatus.Sodium chloride has been used here as a hydrodynamic calibrator, and the system checked with ascorbic acid and propantheline bromide as model drug substances, cornstarch and microcrystalline cellulose as model excipients and salicylic acid acetylsalicylic acid tablets as model tablets.

Cited by 4

Handbook of Dissolution Testing

Christopher G. Bryan, Gray Vivian, Hanson Royal · 2025

Over 20 years ago the Third Edition of the Handbook of Dissolution Testing was published. During that time to the present, new regulatory expectations, new compendial chapters and guidances, new equipment especially for special dosage forms, and more meaningful dissolution test media and conditions have significantly influenced every aspect of dissolution testing. This new Fourth Edition expands and details these topics providing regulatory agencies, educational institutions, and manufacturing labs in every corner of the globe the new information necessary to improve pharmaceutical quality. The Handbook is authored by Bryan Crist, Vivian Gray, and Royal Hanson.

Cited by 2

Dissolution and Drug Release Testing

Vivian A. Gray · 2008

Dissolution Testing is a critical part of the characterization of the drug product. The testinvolves an elaborate sample preparation step, where the product dissolves under con-trolled conditions using prescribed equipment. This chapter will describe the equipment,sources of error when performing the test, how to validate the method and qualify theequipment, and lastly how to develop methods from simple dosage forms to the morenovel dosage forms of today.

Cited by 1

Dissolution of Associational Life? Testing

The Individualization · 2010

Ó The Author(s) 2010. This article is published with open access at Springerlink.com Abstract In this paper we examine whether individualization and informalization processes have occurred in the field of leisure in The Netherlands, by analyzing the social context of a wide range of activities between 1975 and 2005. We find that the choice of a particular leisure context is dependent on education, gender, year of birth, age and time pressure. We find evidence for informalization, but—contrary to popular belief—not for individualization. The informalization trend follows a pattern of cohort replacement, and is also caused by a rise in the average education level in the population. Our findings imply that research on civil society, community and social capital should not only be concerned with membership rates, but also with participation in alternative social contexts.

Cited by 0

Pooled Dissolution Testing: A Primer

Royal Hanson, Michael E. Swartz, Robert J. Jarnutowski · Dissolution Technologies · 1998

IIPf,III7!1 1i-rb Sfl'pbl'llsOIl. ,\11 f)J: I,ee T Gml(V of US' I) btls pro/lww/ (I 1J ('71' !"bor-.I'{fi.l;J1P,' /lie/bod jiJl" disJollltioll lestillg. Tbe propo,wd clfl/.'ji;r 1t'.Ilillp.: ~r poo/cd SlIwp/e.r, fbcrd~)I reducillg tbe {/1111~)lfi((l1 ",,}"dcII. J/Ji.l' art ide n'7. ' it'7.1',1" Ibe prilloiJie.f bebilld fbI' US'P propo,wtl. {/.1 'iN/! liS 171'0 prflt/icrt/ Jl/l'lbotlrJor {fcbievillg poolcd di.I".I-u/lllioll feslillp;. .field oIdh)'olutioJl fest illg. For Ibe pr.ft lime ill 25 ye(ll:l', (I fill1dmll(,l1/(ll p(lmdigfll .I'/;ij1 is heillg ulji"w/ ill (lfl ("'If~ylirtll ta/;-lIifJue -({lId il provir/('s 1101/01' fill illl'rM,fl'. bUf II redllctioll of fbt' mrrml diy.;solmioll n'or/.: IOfld,A! its first level, poolcd disso-Ifflioll reI(,I), to ({.\)'(~yillg II pooled sfllJlplcj;WII illdividlllli disso-Imioll /.'('.11'('/s, simplij)lillg Ibc mrrellf /(I.\'k 0/1I11111iple (1II11~yses )i'OIll illdit'id(llli VC .... fl'/s, IlIId IbllS providing some relitf to Ibe '1II1I~)lti({f1 hllrdcn. /L l t its ,I'uo"d ICi'l'I, pooled di.l:wllltiolJ refers 10 Ibl! Il'.fling o/lIIlIltiple IIlIits ill II singh' iH!SS(,I. t1(birvillg j,ti/! grl'll/cr 7.:ork 10lld sirvillg:fjur Ibe 1II0dcrll dissolmioll IlIb, II is "lm .Wf'!{f!;c.I'ted tblll II 1lC7l l llp/,lIrttlll.l'jor feslillg IJ/ultiple IIllits in II singl(' vf.lTl'1 fllfI)' hl' (oJI.I'idl'I'i'd. '/'bis IIrlide provides 1111 OVl'/7.'il'7!' oIlb' lll'7f USP proposIII. fllollg wilb 17.1 ' 0 pmrfiml IIIl'lbot/xIar pooled dissolulioJl Il'.rtiJlg Iblll flrc IIlIflil/flb/e witb cOIJ/Jllcrcill1 e(/lIipIII'1I1 m:(fil"b/e totl,,)', tl'l' 7: Grtu{V. director of/he Drllg S',,,"t/ffrd,,' Djzli.rioll o/Ibi' Ulli/cd S'/tl/l'S Pbllrlllllcopeifl (USP), blls propo.fcd II /Ie'i.i' (Oll((,/,' ill tlJe field ofdij)'olutioll testillg: pookd fH,'JO/lllioll (J). A h~v prill{iplt ill fbir proposlIl is fbe "b"lr/; c/JlI/'(f(/cri.\'fi(" ofdi,\'.\'ollllion Intillg, IIlId II primlllY bene}if is tb(, "redll(lioll o/Ibi' (/J/(/-~yliml burr/clI, ,. U.\'P blls dl7110llslmlcd ilSelf fo b(' (/ jiu7:'flrdlookillg. 1Lorld-dIlS.r OIgllJlizlltioll l~)' 11I/':illJ!, Ib(' Imd iJl such flrf!({S /1,1' fbe inferJl/ltiollll1 b(lI"IIIOlli::"fltioll ofsfflJldanh IIml Ibe elll!irOIllJll'1!1111 iJllparl o/flloderlll/JIfl~yti(l" rrlll/in'mel/lSjiJr rmgellls (2), ,)'ip.:"ij;mll/~y, Ibis 1Il'71' proposlIl is bi.\'torh ill 1/.1(' Currer>I .... 1!'(>(I

Cited by 0Open access