Laboratory Manual

PRINCE SATTAM BIN ABDULAZIZ UNIVERSITY COLLEGE OF PHARMACY DEPARTMENT OF PHARMACEUTICS AL-KHARJ KINGDOM OF SAUDI ARABIA

Laboratory Manual STERILE DOSAGE FORMS PHT- 434 LEVEL IX

Name of the student:______

Student ID No:______Course Co-ordinator

Course Supervisor Dr. Mohammad Khalid Anwer Email : [email protected]

ACADEMIC YEAR LABORATORY MANUAL MANUAL LABORATORY ...... STERILE DOSAGE FORMSSTERILE h otn sd i reproducible is used content The the understandingthe theoryof topics than explore to more experiments prescribed be and may There chemical instrument. of fully the availability upon or depending or substituted partially experiment of experiment content The type. model as only serve will manual This uig eprmn l the strict occurrence all avoid to rules GLP follow GMP/ to have experiment participants During for only laboratory use and research. is prepared product The the from supervisor. permission after only Labo 1437/1438 _2017/20181437/1438 First semester First r a t o r y Manual . .

7. 6. 5. 4. 3. 2. 1. o Sl.n 11. 10. 9. 8. LABORATORY MANUAL MANUAL LABORATORY the the subject. in laboratory on for its better of andunderstanding Calculations based theory implementation ADMIXTURE IV THEORY CALCULATIONS BASED IN FORM DOSAGE OPHTHALMIC THERAPYREPLENISHMENT FLUIDS AND ELECTROLYTE (ANTIBIOTIC)LVP-INFUSION SVP-SATBILIZER(EDTA) . SVP “ BYISOTONICITY ADJUSTMENT OF LVP-DEXTROSE NORMAL CATAGORY CRYOSCOPIC METHOD” STERILE DOSAGE FORMSSTERILE

SALINE Main subjects which Prepare and submit 5 % W/V of 250 ml of 5%W/V of250ml and submit Prepare ofsodium solution chlorideIsotonic TITLE Calculations involving IV admixture IV involving Calculations HCL ciprofloxacin P ofORS Preparation infusion for 2mg/mlsolution Ciprofloxacin USP injection, acid ofascorbic Preparation 1% with BP preservative injection Lidocaine HCLinj. procaine 1%of adjusttonicity ofprepared the To solution.dextrose solution? of0.15M Prepare 500ml How Na H induced in-situ ophthalmic gel of ophthalmic in-situ induced willbecoveredinthelabs 2 CO 3

09 03 Pg No 22 21 19 18 16 14 13 11

LABORATORY MANUAL MANUAL LABORATORY laboratory. follow sterile strictly norms to the of is advisable 5. It 4. 3. 2. 1.

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o Wear head, mouth and shoes disposable masks to maintain the sterility of thelab. of sterility the maintain masksto andshoesdisposable mouth head, Wear

atta Alwaysbringwithyou: as abadge. Pharmacist" a be to proud Anametagwithyourfullname,PharmacyStudentasatitleand"I‘m Wear supervisor. by discussionconcerned time with same free in the attend arranged lab makeup a and instructor the with discussed be must absence the for reason the Ifalabismissed, Allstudentsmustcompletealllaboratoryassignments. laboratory the in while coats lab white clean, wear must students All

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LABORATORY MANUAL MANUAL LABORATORY ¥ and basedlaboratory is coursestudy.maximum grades onthe routine shareofthe * Grading* Grading pattern subjected to change depending on the instruction directedby the higher authority, the the directedby higher onthe subjectedinstruction pattern changedepending to Grading May be substitutedMay byother be activity.

Int STERILE DOSAGEFORM:PHT-434 STERILE DOSAGE FORMS r oduction & grading about the Course Outline Course the about grading & oduction Total Total workHome Record Laboratory Practice Good Quiz Minor experiment Major experiment LaboratoryManual: Level IX 5 10 25 2 3 2 3 ¥

"Terminal Sterilization"."Terminal not by filtration are sterilized 4. They use time formultidoseorseveral are meant 3. They formulation. in their preservatives contains 2. They isbelow 100ml. volume 1. Their VolumeParenteralsSmall LABORATORY MANUAL MANUAL LABORATORY

STERILE DOSAGE FORMS

DIFFERENTIATION OF SVPDIFFERENTIATION LVP OF &

4. They are sterilized by"Terminal Sterilization". sterilized 4. They are single3. They dose. are any type contains 2. Theyofpreservatives. donot 100ml.1. Volume and above is100ml Large VolumeParenterals

LABORATORY MANUAL MANUAL LABORATORY Observations : it and the reagentbottle labeled.of to Transferred stirrer. it mixed distilled properlyaddedThen the help added wateris with Mixed again flask it 500ml. Nacl. upto then and 4.5gm isa in beaker/volumetric areweightedofAt firstof taken balance.distilled 4.5gm 500ml sodiumwith water (Nacl) chloride Procedure Calculations: gum.6. White paperand 5. Funnel 4. Reagent 500ml bottle 3. Stirrer volumetric2. Beaker/ flask 500ml weight box. balance1. Chemical and Requirement = NaCl (0.9 isotonic4.5gm 500 mlNacl *500/100) gm of contain (0.9/100) isotonic1 mlNacl gm of contain 0.9gm isotonic100 ml of contain Nacl 100ml. is 0.9% NaClchloride Theory Aim: isotonic 0.9% NaClchloride Introduction :Isotonic Expt No:

To prepare and submit 500 ml isotonic andsubmitTo 500ml prepare solution. : STERILE DOSAGE FORMS

of apparatus:of solution

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solution Isotonic of solution chloride sodium

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SALINE DATE

LABORATORY MANUAL MANUAL LABORATORY Report: loss fluid excessive loss. with body(dehydration) carbohydrate from the been has there where used is Infusion Intravenous Glucose and Chloride Sodium of source a provides which sugar, simple a is energy. Glucose sodium. of lack or loss water from suffering patients to vein) a (into infusion intravenous by given be can chloride Sodium tissues. and cells body’s the around and in fluid of balance correct the maintain to helps Infusion Intravenous Chloride Sodium Sodium Intravenous Infusion Chloride Indication: p Clarity P H a r STERILE DOSAGE FORMS a m e t er Observation

for intravenous injection as a fluid and nutrientreplenisher. a as fluid injection for intravenous injection for water in dextrose of solution hypertonic non-pyrogenic, sterile, a is USP Injection, Dextrose 5% THEORY of formulation the and haemodialysis dialysis solutions. peritoneal in ingredient essential an also is energy It carbohydrate therapies. a injectable or or infusion agent parenteral isotonic in source active an as used sugar physiological the is glucose or Dextrose INTRODUCTION CALCULATIONS: vehicle. thewith same mark volumethe upto ismade the flask 250mlvolumetric in in 100mlof 12.5gm dextrose water isdissolved forinjection of calculated Then the Therefore for250ml12.5g. 5gm solid solvent. means substance in of 5 %W/V 100mlof METHODOLOGY: USPH2O. designated ischemically forInjection, in water.&Water soluble C6H12O6 designated ischemically Dextrose, USP CHEMICALS INVOLVED the discardedunit. entire with be should portion unused the required, are doses smaller When injection. single-dose a as use for only intended is and adjustment) pH for (except buffer added or and/or agent antimicrobial bacteriostat, hydroxide no contains solution sodium The contain may and 6.5 to 3.2 an of adjustment. forpH hydrochloric acid has pH solution a The (calc.), kcal/gram. mOsmol/mL 3.4 2.53 delivers which of hydrous osmolarity dextrose, g 0.05 contains fluid of mL Each LABORATORY MANUAL MANUAL LABORATORY No:Exp Date PrepareW/V250Dextrose and submit of5 % ml of solution STERILE DOSAGE FORMS

• H2O (D-glucose monohydrate), afreely • H2O hexosesugar

a rate of0.8g/kg/hr.a at infused when retained is dextrose the of 95% About weight/hour. body of g/kg 0.5 is glycosuria producing without infused be can dextrose which at rate maximum The slowly. made be should solution the of Injection administration: peripheralvein For ANDDOSAGE ADMINISTRATION physiologic equilibrium. maintaining in role major a plays (Na+) sodium and compartments body the in electrolytes of concentration the on primarily depends distribution Water mechanisms. regulatory various by maintained is balance Water production). and byperspiration urine loss water insensible for each liters 1.5 to (1.0 liters three to two from ranges requirement adult normal Average weight. body total of 70% approximately for accounts and tissues body all of constituent essential an is Water and water. dioxide oxidationto carbon DextroseInjection action. undergoes sparing protein- a exerts and depletion glycogen liver minimizing in aid may dextrose of form the in Carbohydrate calories.source ofcarbohydrate a provides and hypoglycemia in levels glucose blood restores solution this intravenously administered When CLINICAL PHARMACOLOGY STUDENT NOTE: STUDENT wastage ofchemicals. the excess avoid to only 5% is prepares concentration the preparation lab in but 50% is concentration the image the On Note: LABORATORY MANUAL MANUAL LABORATORY STERILE DOSAGE FORMS

LABORATORY MANUAL MANUAL LABORATORY Formulation: gm/100substance. ofadjusting w conc. ml %= Principle: Glass wares: Chemicals anaesthetic. topical a pointFreezing depression(FPD) as is membrane. procaine for use Tonicity primary The Introduction : Aim No:Exp Date b = f.p.d of 1% of adjusting substance (STANDARDb = substance table) f.p.dof1%adjusting strength X substance f.p.dof1%unadjusted (STANDARD percentage a = table) • • • • ...... : To adjust the tonicity of prepared 1% of Procaine Hcl Inj. 1%ofProcaine tonicity ofprepared :the To adjust Any solution have F.P.Any -0.52ºC isisotonic. have = solution F.P. & -0.52ºC tears = ofblood Fpd of1%NaCl=0.576ºC Fpd of1%drug=0.112ºF.p.d C HCl1%usingNaClAdjust ? isotonicityof ofProcaine 100ml FP -0.52ºC i.e. 0.9% NaCl= isisotonic ). Add f.p.dofblood to to(-0.52º hypotonic reach solute solution FPSolutions with of-0.6ºC hypertonic FPSolutions hypotonic with of-0.4ºC are F.P.Any have ›-0.52ºC ishypotonic solution s a maue o h soi rsue o w ouin eaae y a semi-permeable a by separated solutions two of pressure osmotic the of measure a is : Procaine Hcl,Methyl Paraben, NaCl. Procaine Paraben, Hcl,Methyl : 100 ml X 3 Beaker, Glass 100ml 3Beaker, Rod. X Adjustment point isotonicityby (FPD) of depression Freezing STERILE DOSAGE FORMS Sl.no 4. 3. 2. 1. WFI NaCl PARABENMETHYL PROCAINE HCL Ingridients w “cryoscopic method”.“cryoscopic % “ cryoscopic method”cryoscopic  Upto 100 amount Calculated 0.1 % 1% Quantity 0 . 52 b  Qty (mg) a

LABORATORY MANUAL MANUAL LABORATORY Report: Calculation: Observations: upto 100ml. make volume it upthe and make finally isotonic ofNaCl amount to calculated To add thisthe solution to drug. solution preservative solution clear add gettingthe mix with rodafter glass vigorously 100mlseparately each in WFIin beaker 20ml ofdrugandDissolve theamount preservative required Procedure: p Clarity P H a r STERILE DOSAGE FORMS a m e t er Observation

LABORATORY MANUAL MANUAL LABORATORY Observations: add WFIupto 50ml. then into one solution of twobeakersother by adding content the thoroughly Mix the water, then of amount sufficient beaker in beaker capacity separate ml in dissolved 100 is in preservatives water of ml 20 in it dissolved drug of quantity required the Take Procedur Formulae Apparatu forInjections Water Propylhydroxybenzoate-E216 Methylhydroxybenzoate -E218 hydrochlorideLidocaine Chemical % 0.3 216) (E Propylhydroxylbenzoate hydroxidew/v, sodium sodium hydrochloric(P chloride, acid, w/v, % 1.7 218) (E hydroxybenzoate Methyl include Excipients lab, present the In is range mL 100 to 10 The designedtypically formulti-doseapplications. products. injectable traditional other and vaccines, anesthetics, local include Parenterals Volume Small for Applications ml 100 to 10 - (SVP) Manufacturing Parenteral Volume Small Introductio AIM: No:Exp p Clarity t P er H a r a m To prepare and submit 50 ml of Lidocaine Injection with BP preservative submit ofLidocaine prepare and 50ml To e e s s& wares: glass n LIDOCAINE INJECTION PRESERVATIVEBP LIDOCAINE INJECTION WITH STERILE DOSAGE FORMS Date Sl.no Sl.no Each 50 ml vial contains sterile aqueous solution of lidocaine hydrochloride 1% w/v. 1% hydrochloride lidocaine of solution aqueous sterile contains vial ml 50 Each Observation 4. 3. 2. 1. 3X Water for Injections forInjections Water Propylhydroxybenzoate-E216 Methylhydroxybenzoate -E218 hydrochlorideLidocaine Ingredients SMALL PARENTRAL VOLUME SMALL 100 ml Beaker, glass rod,vial. glass Beaker, 100 ml Calculations: H ) and water forinjection (QS). ) and water Quantity for 50 ml ml 50 for Quantity .

Sl.no LABORATORY MANUAL MANUAL LABORATORY of Formulation aid the with Prepared adjustto P qs. used been Injection have may Acid for Hydrochloric and/or Hydroxide Sodium Water SodiumBicarbonate. in 0.025% Disodium mgandEdetate 250 Acid Ascorbic contains: mL Each solution. sterile a is Injection Acid Ascorbic Preparation: Hydrochloric Acid Hydroxide Sodium Disodium,Bicarbonate, Sodium and/or Ascorbic Acid,EDTA Requirements: Oxygen. Ascorbic Acidand amount the between trace interaction inhibit to have stabilizer a as will (EDTA.) Disodium ofEdetate instead (0.025%) but Preservative no contains Injections Acid Ascorbic Principle: is weight asmolecular follows:176.13. Thestructureis the and C6H806, is formula empirical The acid. Lascorbic is acid ascorbic of name chemical The benzene. in and ether, in chloroform, in alcohol;insoluble in soluble sparingly water; in soluble freely is acid Ascorbic On oxidizes. itrapidly solution product. antiscorbutic an is taste.It in but air, in stable reasonably is it state, dry acidic the In darkens. gradually it tolight, exposure slight slightly a or with white a powder as or occurs yellowcrystal It vitamin. water-soluble a is C) (vitamin acid Ascorbic Introduction: Exp.No Date: Report: 1. PREPRATION OFASCORBICACIDINJECTION, USP Ascorbic Acid Ascorbic Ingredients H . STERILE DOSAGE FORMS , WFI . 250 gm mg/ml 250 For Ascorbic Acid Ascorbic Ingredients 25 ml

LABORATORY MANUAL MANUAL LABORATORY Report Observations: 30°C(59°- temperature, 15°- room 86°F). Store controlled at andLight FromProtect Heat is beavoided. to intravenousinjection Too-rapid Its PrecautionsGeneral scurvy. of Precautions treatment and prevention the loosened teeth. gums,gingivitis,bleeding and for recommended development, tooth and bone faulty with patients for desirable is parenteraladministration is C Vitamin Indications AND Usage Calculations: 4. 3. 2. : WFI Bicarbonate Sodium Disodium Edetate STERILE DOSAGE FORMS p Clarity P H a r a m e t er qs P 5.5-7 For 0.025% H WFI Bicarbonate Sodium Disodium Edetate Observation

LABORATORY MANUAL MANUAL LABORATORY Preparation: Formulations: be 106° at either can are from produced bottles volume applications. (LVP) intravenous Manufacturing Parenteral Volume Large Introduction: Exp.No Date: 3. 2. 1. adjust P the glucose and slowly with inmonohydrate stirring solution the solution acid Now add druglactic beaker adissolve seprate Then in stirring. with continuous acid thequantity ofdrugand 20ml lactic required Take WFIdissolve Ciprofloxacin 2mg/mlSolutionCiprofloxacin forInfusion STERILE DOSAGE FORMS Sl.no H with desired P with desired . 5 . 4 . 3 . 2 . 1 Water for Water injection pH adjustment HydrochloricDilute foracid acid Lactic monohydrateglucose Ciprofloxacin Ingredients LARGE VOLUME PARENTRALS VOLUME LARGE H adjusting agent. adjusting glucose monohydrate in 20mlglucose monohydrate in ofWFI. Formulation 2.5gm 100 mg For ml 50 Qs uptoQs50 ml infusionfrom ranges 3.9 to 4.5 The pH-value of the solution for 1.25gm r yial netbe pout eind for designed products injectable typically are Calculate forCalculate 150 ml150 C or121°C. that autoclaved, resin often a most large parenteral The delivery

LABORATORY MANUAL MANUAL LABORATORY Calculations: OBSERVATION growth observed forcrystal and respectively forsixweeks 45°C 37°C,40°Cand room temperature, at placed refrigeration, formulation10 mlwere prepared of the Crystal Growth Particulate matter at pH25±1ºC. wasScientific meter usingThermo prepared measured The formulations ofthe pH P Evaluation parameters: The particulate matter can be determined by the visual inspection by naked eye beam. byunderlight inspection naked direct bythe visual be determined matter can The particulate H measurement P STERILE DOSAGE FORMS H measurement Particulatematter . CrystalGrowth

• • • and adolescentsChildren • • • • • • • • • • • Adults following forthe ofthe infections treatment solutionisindicated forinfusion Ciprofloxacin indicationsTherapeutic LABORATORY MANUAL MANUAL LABORATORY Report: Inhalation anthrax (post-exposure prophylaxis and curativetreatment) (post-exposureprophylaxis anthrax and Inhalation pyelonephritis and infections tract urinary Complicated in fibrosiscaused cystic by infections Broncho-pulmonary curativetreatment) (post-exposureprophylaxis anthrax and Inhalation and bones joints ofthe Infections otitis external Malignant byGram-negativebacteria skin and softtissue caused ofthe Infections infectionsIntra-abdominal diarrhoea) (e.g. tract travellers` gastro-intestinal ofthe Infections infections tract Genital infections tract Urinary bacteria caused ifby Gram-negative these sinusitisare especially ofchronic exacerbation Acute media otitis suppurative Chronic bacteria due to infections Gram-negative respiratory tract Lower STERILE DOSAGE FORMS

Pseudomonas aeruginosa Pseudomonas

LABORATORY MANUAL MANUAL LABORATORY STERILE DOSAGE FORMS FLUIDS AND ELECTROLYTE REPLENISHMENTFLUIDS ANDTHERAPY ELECTROLYTE Preparation of Preparation of PDF file is attached / isPDF attached file enclosed for thisfor experiment. Oral Rehydration Salts Rehydration Oral

LABORATORY MANUAL MANUAL LABORATORY 1- Preparation: using NaCl,·2H2O. NaHCO3 ,CaCl2 (STFwas and HPMC,fluid simulated prepared tear alginate Ciprofloxacin hydrochloride ,Sodium Chemicals: Materials pH). physico a specific in due to ocular change transition onthe surface polymer viscous are gels situ In eye. the in present conditions sol undergo polymers gelling situ in The concentrations drug 10% only to leads which turnover fluid tear ofaction. site at the available high and drainage nasolacrimal conventional In Introduction : polymers. byusing in situ bioavailability gelling ocular the To enhance Application : Hcl. ofciprofloxacin ophthalmic oftheformulation Novel properties characterise gelation Prepare and Aim : Expt No: STERILE DOSAGE FORMS

oia ptamc amnsrto h ai pre rapid the administration ophthalmic topical P H induced In-Situ of OphthalmicCiprofloxacin Hcl gel C i p r o f S l ox od Co ac i u OPHTHALMIC FORM DOSAGE OPHTHALMIC m In i m n p h a g l y re o g d Ciprofloxacin Hcl 100ml Hcl Ciprofloxacin si i d n r t o i a i e c t o n e h n ( t l %w o s PROCEDURE o ‐ r fIn-Situ Ophthalmic gel of OphthalmicfIn-Situ gel to i d / e ‐ v e hs rniin o xoue t h physiological the to exposure on transition phase gel ( ) % w / v ) 0 0 F .6 .3 1 0 0 F ‐ based liquids that exhibit sol exhibit that liquids based .8 .3 2 ‐ chemical parameter (ionic strength, or strength, parameter (ionic chemical 1. 0. F 3 0 3 ‐ ona os o rg cue by caused drug of loss corneal 1. 0. F 4 2 3 0 0 F .8 .3 5 DATE ‐ to ‐ gel phase gel

LABORATORY MANUAL MANUAL LABORATORY Report: gel Observations : into transformed be must Calculations : an formulation N 0 o The properties: Gelation p F P u T V 2- Characterization paper. filter through was0.2mm this solution filtered coolingbenzalkonium After and upto 100ml made to was theand volume wereadded polymersolution andchloride drugsolution stirring. with cooled was beaker then min, 15 for 85°C about heated was solution this and water, purified containing beaker a in dissolved were HPMC and alginate Sodium . n H nd or h H o isu 2 d c ecla t m 0 m on r e:+ erl g e a e u m , t l tact C i lat r a e g g a i a r) ppe e t h i C y i l n . t w o s a o s l sl n Ge p Clarity P 2 l i ft f a te t w o o · H h a h r 2 r w r s ast r a e l a H n STERILE DOSAGE FORMS l i a f n nex l i mu a or 2 y ng m a c t O a i k e m v e n l c a t en 0 a e t e d a u nd . er t l nd 00 d p ed l ya i at na i a C s ed 8g t g i sol c e b o l ai i Be ar a p ea n ty a n ri v e s f n n k b r st e l D t i u za d e s e y o w i ; id w ra f st d + l o h k ater ( i n + r H i l on S ea t l d g ed ea P T p e i n M u u F H l w n da at mc pto ) C d w a .S i b t ( f o er( asc h % ter la 10 T n l o w F i c q m g r 0 h k w . / i ell s . v ec d b m 0 . a ) e u a g s k ( i e p c n % p ed d t k o g r ia w g e ) w u p rou / t s v as e a i ) a r n d ed n n g e Observation d d p t u r s. e H 0 e 10 si 0 r . m m m 0 .5 n 0 2 a g eter i n i N n 0 10 ed 0 s aCl . 0 .5 f ( 0 b o 2 p y ra H 0 0.0 v 10 0. . S f 6 is ew y 5 7 0 2 u st g ale ho , r 0. 10 N 0. on 0 x u a 5 0 2 a r ics H s m ; C 0 10 + d i . O n - 0 + i g 0 at 2 + 3 i g tal i o e n l at o f i t o h n e i f m or m m e u d lati i a t e on s

LABORATORY MANUAL MANUAL LABORATORY STERILE DOSAGE FORMS

LABORATORY MANUAL MANUAL LABORATORY WeighingNa7.95g of Weight= in grams 7.95 g Weight= in grams 106 0.5 0.15 XX 0.15X Weight 0.5 / = in 106 grams M L weight. Weight X /molecular= in grams Howi.e.gramsmany needed ? How prepare500 can of0.15M you ml Na Solve: Molwt = 106) Na prepareHow canyou 500ml of0.15M STERILE DOSAGE FORMS 2 CO 3 & placed in volumetric flask involumetricml &placedflask to500 . 500 & diluted up ml Write theprocedure: 2 CO 3 solution solution ? 2 CO 3 solution ?i.e. Howmanysolution ?i.e. needed?(Na grams 2 CO 3

LABORATORY MANUAL MANUAL LABORATORY Solve:        • • ml, how many milliliters should be added to the dextrose injection? dextrose addedinjection? to the millilitersml, howmany shouldbe 10 per mg 50 contain that injection reconstituted a from obtained be to is B amphotericin the If injection. added to 500mlof tobody 5%dextrose weight be of kg per B amphotericin of mg 0.25 for calls kg 70 weighing patient a for order medication A 17.5 mg50ml 17.5*10/ 1 mg50ml 10/ 50 mg 10ml 50mg contain Reconstituted per solution 10ml 0.25 x70= 17.5mg neededforpatient:Total the quantity STERILE DOSAGE FORMS Calculations involvingCalculations admixture IV = 3.5ml

LABORATORY MANUAL MANUAL LABORATORY oe bsc apcs o h various the of aspects with basic students some pharmacy familiarize designed are this of parts practical The therapy. electrolyte and fluid of fundamentals the covers also course the addition In parenteral preparation, admixture andpackaging. large- , volume preparation emphasized: thus sterile small-volume are about forms issues dosage following The formulation, andacid-baseisotonicity properties. and design dosageproperties, physicochemical the ophthalmic including forms and injectable STERILE DOSAGE FORMS STERILE DOSAGE FORMS