ASTM_D_7077_-_04.pdf

Designation:D 7077 04Standard Test Method forEvaluation of Drop Size by weight of Solutions andSuspensions1This standard is issued under the fixed designation D 7077;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This standard test method uses a simulated in-use studyto measure the drop size by weight and to determine thenumber of drops per container for solutions and suspensionscontained in a package system designed to deliver productdrop-wise through a controlled size orifice by squeezing orcompressing the package.1.2 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and to determine theapplicability of regulatory limitations prior to use.2.Terminology2.1 Definitions:2.1.1 Average drop size per dosing intervalThe averageweight of a drop of product dispensed from a given packagewithin a given dosing interval.2.1.2 Average drop size per packageThe average weightof a drop of product dispensed from a given package consid-ering all dispensed doses.2.1.3 Controlling orificeA dispensing plug which fitssnuggly enough in the mating bottle to form a seal,therebyforcing all fluid exiting the package to travel through the plug.2.1.4 Dosing intervalThe time period between productdosings.Testing may be performed“as per label directions,”which means testing is performed at time intervals defined bylabel directions(for example,once daily).Alternatively,testingmay be performed“continuously,”meaning that a shorter timeperiod between dosing intervals is used in order to expeditetesting.2.1.5 Drop sizeThe weight of a single drop of productdispensed from a package designed to deliver product througha controlling orifice.2.1.6 Unsolicited dropsAn amount of product that comesfrom the container without the user squeezing the container.2.1.7 VariableDifferent plugs,closures,bottles,or formu-lations.2.1.8 VolcanoingSpewing forth of the product upon initialopening of the container/closure system.3.Summary of Test Method3.1 Drop size tends to be highly subjective given all thepotential variables,however,it is an essential element indescribing the dosage delivered from a specific package.Thistest method is structured to mimic patient use of an solution orsuspension that is delivered through a controlling orifice todetermine an average drop size for the product.The averagenumber of drops per container will then be calculated from thedata collected.4.Significance and Use4.1 This test method may be used to measure the drop sizeand the number of drops per container for solutions andsuspensions in a specific package system.5.Apparatus5.1 For drop size testing solutions and suspensions,thefollowing equipment is required:5.1.1 Analytical balanceaccurate to 6 0.0001 gram.6.Reagents and Materials6.1 Bottles,plugs,and closures that are representative of thedesired package system under investigation.6.2 It is strongly recommended that actual product be usedfor this test.However,it is recognized that in some instancesactual product may not be available.In this case a fluid that hassimilar viscosity and dispensing characteristics as the productunder investigation should be used.7.Hazards7.1 Any remaining test product should be disposed of in aresponsible manner.7.2 The disposal requirements of the available MSDS forthe product,or key ingredients of the product,or both shouldbe observed in disposal.8.Sampling,Test Specimens,and Test Units8.1 Ten test samples are recommended for testing.A testsample is defined as a complete unit consisting of the bottle,plug,and closure intended for use;and the package should be1This test method is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility of Subcommittee 10.32 on Consumer,Pharmaceutical,and Medical Packaging.Current edition approved Oct.1,2004.Published October 2004.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.filled with the appropriate fluid.The fill level should beconsistent with the level intended for market.Unless otherwisespecified,samples are to be unopened and unused at thebeginning of the test.8.2 The test samples should be labeled with the productlabel and adhesive intended for marketing.The label will addstiffness,or a more durable gripping surface,or both;therefore,it could potentially impact the“squeezability”of the finishedpackage.8.2.1 Number all test samples sequentially.8.2.2 Prepare each test sample by removing all tamper-evident features,(i.e.,shrink bands,tamper-evident ring).9.Preparation of Apparatus9.1 Ensure the balance weigh pan is clean and free fromdebris.10.Calibration