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CAPSULES SHUBHRAJIT MANTRY Asst.Prof Kottam Institute of Pharmacy . A.P 6/29/2011 1 KOTTAM INSTITUTE OF PHARMACY

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Capsules are solid dosage forms in which drug substance is enclosed within hard or soft soluble shell. The shells are generally formed from gelatin. INTRODUCTION Capsules are of two types Hard gelatin capsules Soft gelatin capsules 6/29/2011 2 KOTTAM INSTITUTE OF PHARMACY

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These capsules are made up of gelatin blends, small amount of certified dyes, opaquants, plasticizers and preservatives. Certified Dyes Colour approved by D & C act. Opacifiers Tio2 Plasticizers Sorbitol, Glycerin. Preservatives Propyl and Methyl Parabens 6/29/2011 3 KOTTAM INSTITUTE OF PHARMACY

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GELATIN Gelatin is heterogeneous product derived by hydrolytic extraction of animal's collagen. The sources of gelatins including animal bones, hide portions and frozen pork skin. TYPES OF GELATIN Type A Type B 6/29/2011 4 KOTTAM INSTITUTE OF PHARMACY

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There are two basic types of gelatin TYPE A Derived from acid treated precursor that exhibits an iso electric point at pH-9. It is manufactured mainly from pork skin. TYPE B Derived from alkali treated precursor that exhibits an iso electric point at pH-4.7. It is manufactured mainly from animal bones 6/29/2011 5 KOTTAM INSTITUTE OF PHARMACY

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Preparation Of Gelatin 6/29/2011 6 KOTTAM INSTITUTE OF PHARMACY

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MANUFACTURE OF EMPTY GELATIN CAPSULES Steps involved in making empty gelatin capsules… Dipping Spinning Drying Stripping Trimming and Joining Polishing 6/29/2011 7 KOTTAM INSTITUTE OF PHARMACY

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Dipping : Pairs of the stainless steel pins are dipped into the dipping solution to simultaneously form the caps and bodies. The dipping solution is maintained at a temperature of about 50 0 C in a heated, jacketed dipping pan. Spinning : The pins are rotated to distribute the gelatin over the pins uniformly and to avoid the formation of a bead at the capsule ends. Drying : The gelatin is dried by a blast of cool air to form a hard shells. The pins are moved through a series of air drying kilns to remove water Stripping : A series of bronze jaws strip the cap and body portions of the capsules from the pins. 6/29/2011 9 KOTTAM INSTITUTE OF PHARMACY

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Trimming and joining The stripped cap and body portions are trimmed to the required length by stationary knives. After trimming to the right length, the cap and body portion are joined and ejected from the machine. Polishing Pan Polishing : Acela-cota pan is used to dust and polish. Cloth Dusting : Capsule are rubbed with cloth. Brushing : Capsule are feed under soft rotating brush. 6/29/2011 10 KOTTAM INSTITUTE OF PHARMACY

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Capsules are tasteless, odorless and can easily be administered. There are attractive in appearance. The drugs having un-pleasant odor and taste are enclosed in a tasteless shell. They can be filled quickly and conveniently. Physician can change the dose and combination of drug according to patient requirement. They are economical. They are easy to handle and carry. ADVANTAGES 6/29/2011 11 KOTTAM INSTITUTE OF PHARMACY

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DISADVANTAGES Hygroscopic drugs are not suitable for filling into capsules, because they absorb water present in capsule shell makes shell very brittle and ultimately lead to crumble into pieces. The concentrated solutions which require previous dilution are unsuitable for capsules because if administered as such lead to irritation into stomach 6/29/2011 12 KOTTAM INSTITUTE OF PHARMACY

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Capsule size For human use, empty capsules ranging in size from 000 the largest to 5 the smallest. Generally, hard gelatin capsule are used to encapsulate between 65 mg to 1 gram. Size Volume in ml Size in mm 000 1.37 26.3 00 0.95 23.7 0 0.68 21.8 1 0.50 19.2 2 0.37 18.3 3 0.30 15.3 4 0.21 14.7 5 0.15 11.9 6/29/2011 13 KOTTAM INSTITUTE OF PHARMACY

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The largest size of the capsule is No: 000. The smallest size is No: 5. The standard shape of capsules is traditional, symmetrical bullet shape. SHAPES OF CAPLUSE 6/29/2011 14 KOTTAM INSTITUTE OF PHARMACY

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Types Hard gelatin capsules Soft gelatin capsules 6/29/2011 15 KOTTAM INSTITUTE OF PHARMACY

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Hard Gelatin Capsules These are used for administration of solid medicaments. The capsule shell is prepared from gelatin colours and titanium dioxide make it opaque. It consists of two parts i.e. body and cap. The powdered material is filled into the cylindrical body of the capsules and then the cap is placed over it. USED AS Extemporaneous compounding of prescription 6/29/2011 16 KOTTAM INSTITUTE OF PHARMACY


PARTS OF HARD GELATIN CAPSULE 17 CAP BODY Hard gelatin capsules consist of two sections: (1) The Capsule Body (2) The Capsule Cap The two parts overlap when joined, with the capsule filling snugly over the open end of the capsule base. 6/29/2011 KOTTAM INSTITUTE OF PHARMACY

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EXCIPIENT USED IN FILLING OF CAPSULES There are following additives used in capsule formulation Diluents : the diluent is needed where the quantity of medicament is too small in bulk to get it filled in the smallest available capsule size diluent is added to bring the medicament up to the desired bulk e.g. commonly used diluents are lactose , mannitol , sarbitol, starch e.t.c. Absorbents :- the medicaments such as hygroscopic substances are physically in compatible with each other so absorbents e.g oxides & corbonates of magnesium & calcium & kiolin are added to the powdered drug . these inert materials act as a protective sorbent. 6/29/2011 20 KOTTAM INSTITUTE OF PHARMACY

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Glidants:- these are used to ensure a regular flow of powder in to automatic capsule machine & are mixed with the medicaments e.g. talc magnesium sterate & calcium sterate. Antidusting compounds :- During filling of capsules in automatic capsules machine a lots of dust is coming out which can create health hazard to the operator & working in the production area . to avoid this components like inert odible oil are added in to the formulation which act as antidusting compounds. 6/29/2011 21 KOTTAM INSTITUTE OF PHARMACY

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1. Once raw materials have been received and released by Quality Control, the gelatin and hot demineralized water are mixed under vacuum in Stainless Steel Gelatin Melting System. 2. After aging in stainless steel receiving tanks, the gelatin solution is transferred to stainless steel feed tanks. 3. Dyes, opacifants, and any needed water are added to the gelatin in the feed tanks to complete the gelatin preparation procedure. The feed tanks are then used to gravity-feed gelatin into the Capsule Machine. 4. From the feed tank, the gelatin is gravity fed to Dipper section. Here, the capsules are molded onto stainless steel Pin Bars which are dipped into the gelatin solution. 6/29/2011 22 KOTTAM INSTITUTE OF PHARMACY

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5. Once dipped, the Pin Bars rise to the upper deck allowing the cap and body to set on the Pins. 6. The Pin Bars pass through the upper and lower kilns of Capsule Machine Drying System. Here gently moving air which is precisely controlled for volume, temperature, and humidity, removes the exact amount of moisture from the capsule halves. 7. Once drying is complete, the Pin Bars enter the Table section which positions the capsule halves for stripping from the Pins in the Automatic section. 8. In the Automatic section, capsule halves are individually stripped from the Pins. 9. The cap and body lengths are precisely trimmed to a ±0.15 mm tolerance. 10. The capsule bodies and caps are joined automatically in the joiner blocks. 6/29/2011 23 KOTTAM INSTITUTE OF PHARMACY

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11. Finished capsules are pushed onto a conveyer belt which carries them out to a container. 12. Capsule quality is monitored throughout the production process including size, moisture content, single wall thickness, and color. 13. Capsules are sorted and visually inspected on specially designed R&J Inspection Stations. 14. Perfect capsules are imprinted with the client logo on high-speed. 6/29/2011 24 KOTTAM INSTITUTE OF PHARMACY


25 FILLING OF HARD GELATIN CAPSULES Hand Operated methods. Semi Automatic Capsules Devices. Automatic filling machine. 6/29/2011 KOTTAM INSTITUTE OF PHARMACY

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Various Filling Machine Available… Eli-lily and Co Farmatic Hofliger and Karg Zanasi Parke-Davis. These machine differ in there design and output 6/29/2011 26 KOTTAM INSTITUTE OF PHARMACY

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Process Capsule Filling 1. Milling /Sieving of all Ingredients 2. Blending Powder Blender / Empty Capsules 3. Capsule Filler 4. Capsule cleaner/deduster 5. Capsule injection screen 6. Capsule check-weighing system/reject 7. Finished capsules 8. Packaging 6/29/2011 27 KOTTAM INSTITUTE OF PHARMACY

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Machines for industrial use The process of working: separating the caps from empty capsules → filling the bodies → scraping the excess powder → replacing the caps → sealing the capsules → cleaning the outside of the filled capsules 165,000 capsules per hour Filling hard capsule shells 6/29/2011 29 KOTTAM INSTITUTE OF PHARMACY

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HAND OPERATED CAPSULE FILLINGMACHINE It is having following parts:- Bed having 200-300 holes. Loading tray having 200-300 holes. Powder tray. Pin Plate having 200-300 pins. Sealing plate having rubber top. Lever Cam handel 6/29/2011 30 KOTTAM INSTITUTE OF PHARMACY

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Hand-operated Capsule Filling Machine 6/29/2011 31 KOTTAM INSTITUTE OF PHARMACY

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1.) Load capsules into the tray. 2.) Place tray on Filler. Note that sliding frame should be pulled out. 3.) Pull cam handle towards you to lock capsule bodies in machine. 4.) Hold rear handle and push down on the locking lever to separate the capsules. 6/29/2011 32 KOTTAM INSTITUTE OF PHARMACY

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5.) Set aside the tray containing all the caps . 6.) Push the cam handle away from you to drop the bodies so they are even with the top sheet. 7.) Place the powder tray onto the Filler. The tray will keep powder from spilling. 8.) Pour & spread the pre-measured powder. Move extra powder onto the powder reservoir. 6/29/2011 33 KOTTAM INSTITUTE OF PHARMACY

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9.) Lower the tamper and lock it using the “C” clamp. 10.) Turn the tamping plate screw handle to compress the powder. This allows you to fill more powder in each capsule. 11.) Raise the tamper & spread extra powder from the reservoir into the capsules. Be sure to turn the tamping screw counter-clockwise before raising the tamper. 12.) Return the tray containing the caps to the Filler. 6/29/2011 34 KOTTAM INSTITUTE OF PHARMACY

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13.) Push the sliding frame in and lower the locking plate. 14.) Push down on the locking lever handle. The bodies are pushed up into the caps and all the capsules become locked in one step. 15.) Lift the locking plate and pull the sliding frame out to set for next batch of capsules. 16.) Remove the capsule tray and you now have filled, locked capsules ready for packaging! 6/29/2011 35 KOTTAM INSTITUTE OF PHARMACY

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Filling of Capsules CAPLETS PASTES LIQUIDS w/ capseal 6/29/2011 37 KOTTAM INSTITUTE OF PHARMACY

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Tamper evident capsules by sealing the joint between the 2 capsule parts Distinctive looking capsules by sealing them with colored band of gelatin (Kapseals). If removed, the band cannot be restored without expert sealing with gelatin 3. Through a heat welding process that fuses the capsule cap to the ring around the capsule where heat welded Example: Weld’s gelatin seal Capsule Sealing 6/29/2011 39 KOTTAM INSTITUTE OF PHARMACY

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Liquid wetting agent that lowers the melting point in the contact areas of the capsule’s cap and the body using low temperatures (40-45 0 C) 5. Lightly coating the inner surface of the cap with a warm gelatin solution immediately prior to placement on the filled capsule body. 6/29/2011 40 KOTTAM INSTITUTE OF PHARMACY

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Soft Gelatin Capsules Definition:- Soft Gelatin capsules are one piece, hermetically sealed, soft gelatin shells containing a liquid, a suspension, or a semisolid. Soft gelatin is mainly composed of gelatin, plasticizers, preservative, colouring and opacifying agents, flavoring agents and sugars. 6/29/2011 42 KOTTAM INSTITUTE OF PHARMACY



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45 SHAPE OF CAPSULE The shape of soft gelatin capsule are round, oval, oblong, tube. 6/29/2011 KOTTAM INSTITUTE OF PHARMACY

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47 1) liquids a) water-immiscible volatile and nonvolatile liquids b) water-miscible, nonvolatile liquids c) water-miscible and relatively nonvolatile liquids e.g. propylene glycol , isopropyl alcohol d) Liquids that can easily migrate through the capsule shell cannot be encapsulated into soft gelatin capsules 2) solids (solutions, suspensions, pasty mass, dry powders, granules, pellets, or small tablets.) The fill material of soft gelatin capsules 6/29/2011 KOTTAM INSTITUTE OF PHARMACY


48 MANUFACTURE OF SOFT GELATIN CAPSULES Is manufactured by four methods Plate process Rotary die process Reciprocating die Accogel machine 6/29/2011 KOTTAM INSTITUTE OF PHARMACY

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49 Place the gelatin sheet over a die plate containing numerous die pockets. Application of vacuum to draw the sheet in to the die pockets. Fill the pockets with liquid or paste. Place another gelatin sheet over the filled pockets, and Sandwich under a die press where the capsules are formed and cut out. Plate process: 6/29/2011 KOTTAM INSTITUTE OF PHARMACY

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Rotary die press: 1) In this machine the soft gelatin capsules are prepared & then filled immediately with liquid medicaments it is having two hoppers & two rotating dies 2) Liquid mixture is placed in one hopper & the liquid medicament in other Hooper. 3) The two rotating dies rotate in opposite directions when the fluid gelatin mixture enters the machine from the hopper it produces two continuous ribbons . 4) These half shell of the capsule is formed. 6/29/2011 50 KOTTAM INSTITUTE OF PHARMACY

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5) At this stage the measured quantity of the medicament is filled in to it with the stroke of a pump with the subsequent movement of the dies the other half capsule is formed. 6) The two halves' of the capsules are sealed together by the heat & pressure of the rotating dies. 7) As the die rolls rotate, the convergence of the matching die pockets seals and cuts out the filled capsules 6/29/2011 51 KOTTAM INSTITUTE OF PHARMACY



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Accogel Capsule Machine Or Stern machine, uses a system of rotary dies but is unique in that it is the only machine that can successfully fill dry powder into a soft gelatin capsule. Accogel Capsule Machine 6/29/2011 53 KOTTAM INSTITUTE OF PHARMACY


MANUFACTURING SOFT GELATIN CAPSULES 1.Composition of the shell The basic component of soft gelatin shell is gelatin; however, the shell has been plasticize The ratio of dry plasticizer to dry gelatin determines the “hardness” of the shell and can vary from 0.3-1.0 for very hard shell to 1.0-1.8 for very soft shell Up to 5% sugar may be included to give a “chewable” quality to the shell The residual shell moisture content of finished capsules will be in the range of 6-10%. 6/29/2011 54 KOTTAM INSTITUTE OF PHARMACY

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Formulation : Formulation for soft gelatin capsules involves liquid, rather than powder technology. Materials are generally formulated to produce the smallest possible capsule consistent with maximum stability, therapeutic effectiveness and manufacture efficiency. The liquids are limited to those that do not have an adverse effect on gelatin walls. Emulsion can not be filled because water will be released that will affect the shell The pH of the liquid can be between 2.5 and 7.5 . 6/29/2011 55 KOTTAM INSTITUTE OF PHARMACY

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The types of vehicles used in soft gelatin capsules fall in to two main groups: Water immiscible, volatile or more likely more volatile liquids such as vegetable oils, mineral oils, medium-chain triglycerides and acetylated glycerin. Water miscible, nonvolatile liquids such as low molecular weight PEG have come in to use more recently because of their ability to mix with water readily and accelerate dissolution of dissolved or suspended drugs. All liquids used for filling must flow by gravity at a temperature of 35 0 C or less. The sealing temperature of gelatin films is 37-40 0 C 6/29/2011 56 KOTTAM INSTITUTE OF PHARMACY

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DIFFERENCE BETWEEN HARD GELATIN & SOFT GELATIN CAPSULES HARD GELATIN CAPSULES Two piece (large body & short cap) Cylindrical shape. Powder drug or pallets coated with drug are encapsulated. Gelatin in Hard form is used. Capsules are sealed after they are filled to ensure that the medicaments may not come out of the capsule due to rough handling. 8 different type of sizes are available SOFT GELATIN CAPSULES One piece & hermetically sealed. Available in round , oval & tube like shapes. Liquid & Semi liquid fill & unstable substances are encapsulated. Molten gelatin are used. Filling & sealing of soft gelatin capsules are done in a combined operation on machine. No specific sizes are available. 6/29/2011 58 KOTTAM INSTITUTE OF PHARMACY

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EVALUTION OF CAPSULES:- Following test is carried out for evaluation of capsules: (1)Uniformity of weight (2)Content of the active ingredients in the capsules (3)Disintegration test (4)Dissolution test 6/29/2011 59 KOTTAM INSTITUTE OF PHARMACY

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Weight variation W capsule – W emptied shell = W content 10 capsules labeled amount or average amount, ±10% 1) For hard capsules W capsule should match W emptied shell . 2) For soft capsules evaporating the washing solvent over 30 mins avoid uptake or loss of moisture 6/29/2011 60 KOTTAM INSTITUTE OF PHARMACY

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Content uniformity The amount of active ingredient should be within the range of 85% to 115% of the label amount for 9 of 10 capsules, with no unit outside the range of 70% to 125% of label amount. 6/29/2011 61 KOTTAM INSTITUTE OF PHARMACY

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Disintegration test for capsules 1)The capsules are placed in the basket-rack assembly, which is repeatedly immersed 30 times per minute into a thermostatically controlled fluid at 37 ℃ and observed over the time described in the individual monograph. 2) To fully satisfy the test, the capsules disintegrate completely into a soft mass having no palpably firm core , and only some fragments of the gelatin shell. 6/29/2011 62 KOTTAM INSTITUTE OF PHARMACY

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Dissolution test for capsules 1) The apparatus, dissolution media and test is the same as that for uncoated and plain coated tablets. 2) Generally, when a dissolution test is applied to an existing capsule product, the disintegration test is unnecessary. 6/29/2011 63 KOTTAM INSTITUTE OF PHARMACY


PACKING & STORAGE OF CAPSULES Capsules should be packed well closed glass & plastic container & stored at temp. not exceeding 30 0 c Capsules are individually protected by enclosing in strip & blister packaging. In strip packing the capsule is hermetically sealed within the strips of an aluminum or plastic film. The contents are removed from the strip pack by cutting to separate capsules. In blister packs, a press on the blister forces the capsule through the backing strip. Capsules have a larger shelf life in unopened glass bottles than in strip pack & but this is reversed. 6/29/2011 64 KOTTAM INSTITUTE OF PHARMACY

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Official Capsule Commercial Capsule Strengths Category Products usually available Amoxicillin Wymox 250 and 500 mg Antibacterial Ampicillin Omnipen 250 and 500 mg Antibacterial Aspirin 300 mg Analgesic Cephalexin Keflex 250 and 500 mg Antibacterial Cloxacillin sodium Tegopen 250 and 500 mg Antibacterial Diphenhydramine Benadryl HCl 25 and 50 mg Antihistamine HCl Examples Of Some Official Capsules 6/29/2011 65 KOTTAM INSTITUTE OF PHARMACY

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Official Capsule Commercial Capsule Strengths Category Products usually available Doxycycline Hyclate Vibramycin 50 and 100 mg Antibacterial Erythromycin Ilosone 125 and 250 mg Antibacterial Estolate Flurazepam HCl Dalmane 15 and 30 mg Hypnotic Gemfibrozil Lopid 300 mg Antihyperlipidemic Griseofulvin Grisactin 125 and 250 mg Antifungal Indomethacin Indocin 25 and 50 mg Antiinflammatory, Antipyretic, analagesic Loperamide HCl Imodium 2 mg Antidiarrheal Nifedipine Procardia 10 and 20 mg Ca-channel blocker Oxazepam Serax 10,15 and 30 mg Antianxiety Propoxyphene HCl Darvon 32 and 65 mg Analgesic Rifampin Rifadin 150 mg Antiinfective Secobarbita Na l Seconal 30 mg Hypnotic,sedative Teracycline HCl Achromycin V 250 and 500 mg Antibactrial; Antiamebic Antirickettsial Examples Of Some Official Capsules 6/29/2011 66 KOTTAM INSTITUTE OF PHARMACY

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6/29/2011 67 KOTTAM INSTITUTE OF PHARMACY For further details: Shubhrajit Mantry Asst. Prof. Kottam Institute of Pharmacy Mobile. No.- 8142576104 Email ID: Thank you

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