_ ucts CAPSULE sus ey tinged ais alien si ae Tc of, porty ae AHH nah spec swaloneand ines. re fr Ss ig UM dou se sweet ete ea Fava RL Kt I ce san en om ie es sat pion Capsule ar ot wed for hg: Street ponder do ses TLO Y oes materia Caps tse union Pode ad he aa ees ee ime opel of ge es Season ay hee or evened sing ie it eve ms Copsle teal é y Hard pltincapule Sof gli apse Dr filled apse Solble lati o soft elise aps ard gelatin caine made roma mixta of t Gla, ugar and ater eins sri omeony acd plaster S0,:Preseratne TiO, Ops (Some ine) (9. scones uring manuf seit eeopneus ru erved by yr nacional olen staan hemi poperis depen FP Metiod oF easton > pitvahe Thermal deat ete cones common Sur Sin bas, whe connective tise zen pork skin. Get pede <-> neenor Parag -A (Catone) Phamagel-B (Asin) ~Byaddtsimeat — bya treatment oer pt theepin of U9 —tseetic point inte eon of PHA > Moxie of wo ae wed in usual practice ‘Ble ofa nd pork sin eli ate normaly sed fora capsule proton > ne gettin proce tp rm fin but end wo be ary and brit Pork igen vis plastica lait be the lend reds haze or clans in the Finished product. Tea PA: Presi fn cd Bae gelatin oct point PH 5-60 Te Fem ren fest ones Piyush Rook Pbesions rr aLin enone Patininen eae 10 oe ® Mette 2h yaaa ngy 10-30 hrs — 8) (0.0.0) -Hotwaterentaton > Fite —— actu enceinte Contest t Ardy _- Mitt sine * Fihoes ofthe capsuc is conto by The viscosity of “ atin solution, * Speed and time of dy 7 Pstematnc ued iad elt cape > Uptos%s sugared nag (Capsule size» 0 ange Formulation: (@) Ica of ily keds, kar, outa Pes lop) Fie owing pond icant metal Stet ded () For Zonas, Maco, Farmatic hinge he ade must ave sie cl feo cohesive rein ahi om dg dlvey othe capt For fling acetytaieyieacad +) (3) exit wis corm starch for fee owing Lit» sicrocrsaine cellos ed a fais shoul besa Mannitol, MgCO, MgO, Silica), Sich Talc and Tapoxo pnd Glycol eters —Silicones ~ Stcon done j sitcoms are exes dat (ow pometer) — Metal steaae Stearic acid ‘mount of ine nc tens otto om pte dust le ilig operation, Fr xa, Ie ceed “Amount of dent used based on. . © am often it an posty putin cap inrelaonto hanson of te inet we ge the apse The amount of Lubricant and oi (2% or ss) that can be wed Poss Rok Pablo[p- Nahas of MANEESEUFR of empty — + Temperate opin =a + Sohtion temperate 0 — Pin are ated stu he eatin viformly aod the pas Doing By we of yaa dhiienton | Spine By bron jas Trinming By tionary knives | doing Cap and boy are joe | Polishing Polishing the power | ++ Types of formulation fled into hard gelatin capsules Tables, Granules, eles, Dry powder {Preparation of ied hard gelatin capsule oe |. Development and preparing the formulation 2 Proper mixing and blending 4+ Lilly type equipment ~ Powder mast fie owing ‘+ Zonas ype and equipment ~ Have cohesiveness ‘Add compatible excipients ~ Microcrystalline cellulase 1. Filing the eapsule shells 4+ Manual punch machine ‘+ Automatic and Semiautomatic selection of the te of he Cape 4. Capsule sealing ‘+ Mache linked wit filing machine {Banding ~ Two capsule parts are sealed with gelatin band ‘+ Contaet area seal by water and ethanol and thermally bonded at 40-1SC ‘Cleaning and polishing ~ After filing some powder formulation may aere ouside the capa + i ease should meet the appropriate cutetregulatory lis: “Weight variation ist + Content uniformity + Solubility + Disintegration (0) Wight variation test: Roto weigh t ‘Vericap 1200 (7300 capsulefir — - {determined shoud not be ess than 20 nat capsule ae individually weighed and average wee is ‘The test requirement are met ofthe average from the 20 castes en. "act more than wo ofthe individual diferences ar peter than 10% of he average ‘iin mo case any difference is greater than 25% ry dierence is gr oefoum aceyabe cape FINISHING sy by oe en tine an Stn ea ea ei once ri Sr Nea eo oe “sre Reed Energy ofthe ow per X13 sib cpoule are saben (6) Narcap 1200: nee a cl rece, : ieee een Wasered changin deri consan, is “orto wh fecal uring ove ie anti 2 Content worm: 30 capt ae ken, so mtr: ‘St 1st ase diay an be with in A15% of average vt the reanng 20 cape are ase, fat within 136 and none fallout sie 25 se 3: Disintegration: Disintegration time for had eatin apse 30 mina. Dsinesation time fr sf statin capul i 60 minutes, Pan polishing: Accla cota tablet coat ing pans wed to Gus ad polish cape, * Polyurethane oceesclath nr isplaeed in pan Lines Trap remove dust, "par losy appearance 5a dating: Bl led capse ate bed wih clos, impepmaed nine ot YM sing fap manure at age sais one etn Polishing then with xsi (chlor) Proce called sl polishing. Brushing Peed under oan Erweka kea dusting nd polishing machine for hard Cleaning and polishing % Special techniques” When pried on fi eatin capsule ‘machine Seidenader PM60 nay also be use, Product identification information placed upon each capeule (empty) led capsule there may bea chanceaf ' Contanination, Poor print ait leads to damage the cape All imprinting machine operate on a(Rotogranule process) Dosators: wed o measure and deliver the powder aa go Qualiset: Used forte filing of igus in ot eatin cpt, (®) Special. Purpose capsule: For reduction in solubility of capes, Defines solubility mits for empty capsule a elows; (2) Water resistance: Fat to disolve in water at 2010 30°C in 1 minute, (©) Aci slit: Dissolve in es than minutes 0.5 aqueous HC (wi) at 3638, {Pinal teamen Decreases slab of ela and cs king of eatin leu aes place "Resta lobe aoe i product bing filed con ley If eye none a ated fnae ‘wot slubilty pate. sles,3 Apne itn a yey ake 2 iS = SS rr ° < Fi Fe < Fd a 2. Speed and ine of dipping > Emptying capsule moisture content - ( Hoveel qian Copault SOFT GELATIN CAPSULE (SGC) cet its fom genie inate glist 2 Sei 2 Otterpobots capsion of sll: Guan * Psi + yc ‘Preservatives (parabens) + Calouing + Opaciying agent (THO, Tale) + Favourng agent (Ehytvaniin) + Essentials oi . Sugars 4+ Acids and Medicaments’ Scape canbe modified to import + Enteric (Chewable and sustained release properies > Oral dosage fom > ‘Ssppsiories for ecm and vaginal > Nor popular for pediatees Sale dosage application for topical ophthalmic preparation % Foearand nse medicaments * Incosmtc industries capsule may be used for packing of perfumes, shampoos, various sin creams sulon oi ete tht of manufacturing: + Leaer and iron mould + Plate process Piyush Book Publicationjan cose 125-30), High bloom strength, (180-250gm) ae sed in corjuncton withthe capsuation of hygroscopic V=siles ory ‘tendard formula can be modified s0 a8 to require up to SO% less water for satisfactory operation on capsulated machine. % This did forma provide es wate tact sel hyrseop i ate Improve ingredient and physical stability of product Iron: Present in raw gelatin cone. depends onto content ofthe age ant of mater sets manfacar, Gelatin use sos contain >15 ppm ron used in som gelatin capsule because, effets on Od, dik an cosmetic and possible colour eae» component Plasicizer use Propylene glycol Giyerin USP Sorbitol USP Hardness of Gelatin capsile = 54 of dry gelatin Ratio of wt, of water to diy gelatin Vary fom (0.71.3) for water + Fordey gelatin (07-1.0) Hardness] Ratio=Dry lycerine:] Usage Dry gelatin [aa [oan Calo based asoTenng podaed Pre de rit | [ein | ‘Oral, tube vaginal il bar water miseible based shell hardening, Produ designed for temperate areas osit “Tube vaginal oll based shell hardening, product designed for cot ry [sen “push Book Publieations"oF plasticizer and gelatin in ' esses ‘But important is that plasticizer to eatin ratio sma fi ins conta, ‘Addition of medicament to gelatin mass uly not recommenda t 7 For eo nomic purpose 50% gelatin mass ie incorporated ino cape ™ por a Result in $0% loss of added medicaments + Hh active inespensve compound such iy such as tense (maps shel) maybe Swe: colour of apt shel shoul never be gtr tan nts aap cea owing information shoul bell in frmaatonofyeata apn # Effects of agitation 1 Effects of tempera {Efecto dsoltion medium eee eee + Effect of shell component on dissolution rate ‘utere of eapsule content: ‘© Used to dispense liquids and solids, 2 Except for accogel process —capsulation of dry proces. Cant of SGC are: + Liquid + Combination of miscible: i) Solution of solid() in tquidis) ii). Suspension of sais) in guid) Maximum size for Oral use (SGC): Oblong 20,0val~ 16, Round = 9 Types of quid encapsulated in SGC: (Water immiscible, volatile and non volatile liquid example: + Vegetable and animal oil + Aliphatic hydrocarbons * Chlorinated hydrocarbon * Ethers, esters, alcohol and organic acid. ‘i Water miscible, non volatile liquid, example : * Polyethylene glycol.el = ” coal : rpmundscrangie, Pein ene if Twat near cos at vob fom is Mi eaptszt camp gen sosiene Geol i Gomer const! Makes more susceptible fo ea 28 hay oats re em enslverta 2 inpePeatOn at serait peiven yet oo cos fo se sion a active ingredient solvent ve faces So a Acamnromtnt Se ated ecbigetnand opt olan we co = ee si et it ae above ogy ean milion Mont widely sed ligid for human use are oy acre nredient ke Cretibrate Sternbe oil Soyabean ll) 2 Mineo J Not sera example: Peysorbate 80, J povesplee geo (400 and 600) eer sone or in cambton. Trois solution pd suspensions for eapslaion Should be tomngeneu nda free Soul (low by pavity at 20m temperature Should na exceed 25°C f ice sealing temperate isin he range of 37-40. | mutation of suspension For SGC determin minimum caps siz vol vce eapelted mere we ase adsorption: Amount fluid base required pro Dns anion of solide infence by factors suchas es consideration of base adsorption. zed with one gram of slid (5) “Spare sze = Share Physical sae (bous, amorphous crystalline) 3 Density S Mosrur content = Oleopilic or hope nature Determination of base adsorp Sold must be completely wetted by Hui base oF weting agents rey reuied S Forgiycol and nonionic base the aditon 0 For seacale ol tase complete weting of sold nat achieved without a aitive Soy Levitin 2% by weight of oils sed as adie Increase in concentration above 3% no avanage. Wot base Me Ado WE of slid = Specific ravi: of mix (W pe evbie em or per 1623 minins (V) 'S Base adsorption ised to determine Mini per gram factor Mi of soi (BA+s)V y= ALS ‘Lower the base adsorption ofthe solid and higher the density ofthe psu willbe tno sity ofthe mixture de smaller the capsule wi 7 Tht) nd ida red ote etained O84 aerial hasta be capaed done concent om 0 mig es oncentraton 50 mig oI ‘ute caste can accommodate such quantity Pt oa Pao > aTon wey ed = Meare fom ti pending ef el absorbed by ae hated by aig es she th yt + Sehr cosng gain coed B) 5 gusta Pic 2 Tanai wal gay oF ves need gost of Sou esting wit _ paca of ro ein oo gln shel _ Sa tangles wate so Reon siya ate pein ge, role of hoa are eer ine ange of 20-22 © te any of NaCl CH,COON isso ria te an ont leap wold bee form cise 22 i based suspension. For © ato ‘ey cool arama of 4% ape -pealeeuipaent- Foresacting rita sale + + el xearain i done in Pony mir ing sn Homogenization proces sine Equipment | : po ‘aed prle siz bul Homalod ill ‘Stove mill Hoppe mill Urschel emit eins cae sebly pole ‘PHARMACEUTIO mre 000 ana 0 rac ton aie ne si in sed of poss example, rosa stu and Magnesium Oxi (od ih pe ofgtasnant drm sot having deleterious sample, hn odio of magnesia med can ave ele on psa sii. nae i rey east when PEG bases place of ely bE reas, 20.30% in dying re surement and contra recor breakup agglomerates of solids and to make certain ha ‘aon bt es ids and to ake certain hat al solid are wet wit liquid eaters Pah Book Publication2 Samia teers mao en ‘Sey sonal of cape SGC. Sa thay Sah ata ocee «> Demi erin ai ghtempee fet , Pernt ign medicament o become ee portable “Accuatey aod untormiys oPaee ~ ost od soon een flog oe | Sarton Powder ile capaue Compresce be Contd bet 7 Capsule farmultion allows the us fluid dap subsance(loromethorite base) ath ha he oid dese ws Microencapsulation "hi coating to small particles of aids or droplets fi and dispersion, Approwimate parce rire {1-5000 ym) Applica ‘Sustain release medication + Prolonged seton medeation Taste masked chewable bes Powder and suspension ‘Single yer tables conining chewable chemical kcompatibe ingredients formulation concep fr creams, client ero, desing pase, Suppositories aid inecables Provides means of ‘Converting liquid wo solid Altering calodalaba surface prope Providing environmental proteetion CContolling cease charactensics ‘Coating materials: Capable of forming ain that i cohesive with core material (Chemically compatible, nonreactive L ‘Strength, flexibility! impermeabilty optical propertiestheir Application methods and ee [sree soi Se Se aE a Solid and liquid 1 ~ 5000 | — sou oe 00 1 — Seti 30m | ny yng eng | Soden wn sou applicable to Parmaceutcal preparation L, Vacuum deposition ee re at norman oer om comers ran pein Diane bet ipnin emes Se 9 poet, [ES Le i sented ed Leer A an isan So nop deanna 4.Pan coating: Extensively employed for preparation of contol eles. > Coating os soliton o atomized pry . Solvent emoved by passing warming ar over coated sur Spray drying and spray congealing: pee — [Soap ering Spraycongeaing Dapeng Soe mail a Tq ing | Disptsing te cove material ta Tate cow sm ied ravig or noduing the cor |subsiance and spraying or odin te Cornea ae or itonmentalemdton | coating mnt in 0 some eavromentl conn “hey acy gptotaan ofthe coating | where by rave rpisolienion of cost sate sated 1 sper Py Boki eon aaal User mete om rs ttn | . | fcriasemioanomave | Revteponton tate { —— — | Rego ste eet] SE | Won, Fay ac coors, polymer, * SHER. Solid trom trgeratie a mc a aonb MBE + - Aplicabe to paycngeingtecaoe Solvent Evaporation: ‘Cor materi may be either water ake water isle Core materi t Dissolved ordered in canting polymer roton ‘Cove-coting materi mixture dispersed is gid mansfactrng vice phase 1 ‘Coating materials used in Microencapsutation Water soluble Resins; + Geta + Gumanibic + Sure + olyviny yoidones + Carboxyl ethyl cellulose Arabino galt 1 Palys cit Polyvinyl alcohol Water insoluble Resin: Ethyl cllsose + Potyetisene + Poly methacrylate + Polyamies| + Polyethylene vinyl acetate Cetaose nate De + Poly actide-so-ghyeotide 2 Wares and lipid + Paatin oo Static acid oo + Steal aeobot ioe + Glyceryl aceite Enteric Resins: : se + Cellulose acetate phthalate Shret sent te min) ‘eva charcoal re dinate guid ysl ‘Mev ictes camphor mitre Progesterone ~ Kel Tease ‘imi A pale sricro encapsulated core material ‘Sigh water soluble soli iy water sob wah ‘Adsorbet Viale —___| —| | ‘Vole solution Tighly water soluble solid Water soluble enzymes ‘Non-oltileiguid ‘SNe | Porpose of encapsulation Final product form 1 [Taste masking Tibet ‘Selestve sorption Dry powder | Tune masking sustained eave reduced gas ation “Tablet or capsule separation of incompatibes 7 Sustained normalization of atc condition Injectable J | Sustained release conversion of liquid to slid ‘Capsule, Hebe fim for thermal 7 Redon of weal, sustained lease Lotion [7 [Sustained release ‘Varied | [2] Reduce gastric ieritation Capsule > [Per selecivity of enzymes substrates and reaction product Dispersion 10_| Stabilization to oxidation Dey powder Symtetc Water soluble Polymers Natural Water Soluble Polymers ‘+ Polyethylene glycol (PEG) Xanthan Gum + Poljaeryamides + Pectins + N42-Hydroxypropy!) methacrylamide (HPMA) + Dextran + Diving Ether Maleic Anhydride (DIVEMA) ‘© Carraggenan + Pohoxazoline © Guar Gum lyposphates Sodium CMC Polyphosphazenes ‘+ Hyaluronic acid (HA) Albumin