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2.3. Hard capsules manufacture

The Dipping Process of Making Hard Gelatin Capsules:similar process to that patented in 1846

a. Metalic mouds are dipped in a warm gelatin bathb. A film of gelatin is formed around

c. Dry process of gelatind. Extractione. Cutting at the desiring sizef. Sealing and positive closure

Tamper resistance/tamper evidencePrevents inadvertent separation on

handling/shippingMakes liquid/semi-solid filling of hard

gelatin capsules possibleSealed capsules are excellent barriers to O2

Shionogi QualicapsCapsugel div. PfizerPharmaphil (Canada)

Farmacia y Tecnologa FarmacuticaUniversidad de Navarra

Formas Slidas Oral: cpsulasJuan M. Irache



Types of hard gelatin capsules: mechanicallyinterlocking Caps and Bodies

Interlocking rings or bumps molded into the cap and body side-wallsPosilok (Shionogi): two-piece gelatin capsule with its mechanical lock made byindentations in the cap and body. The vented cap indentation allows air to escape whencapsule is closed on high-speed filling machines.Snap-Fit and Coni-Snap (Capsugel)

Lox-it (Pharmaphil)

Traditional Prefit Locked



Coni-Snap (Capsugel)



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Types of hard capsules

Quali-V (HPMC) Shionogi Qualicaps / VCaps (Capsugel): multifunctional two-piece hard shell capsule derived from non-animal sources, which satisfy vegetarianand cultural needs. Additional benefits: chemical stability and low moisture content making it an attractive alternative for hygroscopic formulations. LicapsCapsules: gelatin capsules for containment of liquids and semi-solids. PCcaps Capsules: very small size gelatin capsules that are ideal for oraldosage to rodents in pre-clinical studies. Press-fit Gelcaps: high-gloss gelatin coating that encases a caplet core. Theycombine the best qualities of a gelatin capsule with the density of a tablet. DBcapsCapsules: two-piece gelatin capsules that are designed for double-blind clinical trials. The shorter length facilitates ease of swallowing.

DBcaps Licaps Press-fit



Sealing and Welding MethodsBanding

Original banded hard gelatin capsule - Parke Davis' "Kapseal"Modern banding process - Shionogi's Qualiseal

Liquid sealingCapsugel's Licaps

Licaps



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Dosator Principle



MG2 FuturaDosator Machine36,000 caps/h



Dosing Disc Principle



BoschGKF 1500Dosing DiscMachine90,000/h



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Disadvantages of Soft Gelatin Capsules

Generally, product is contracted out to a limited number of

specialty houses,e.g. Scherer, Banner. Generally more costly to produce than tablets or hard shell

capsules More intimate contact between the shell and contents than with

dry-filled hard shell capsules - stability a concern. Not adaptable to incorporation of more than one kind of fill into

the same capsule (compare with hard shell capsules)



Softgel sizes and shapes



3.1. Formulation of soft capsules

Gelatin: Bloom strength 150 - 200 bloom gramsPure liquids, mixtures of miscible liquids, or solids dissoved or suspended ina liquid vehicle. Vehicles

Water immiscible non-volatile liquids vegetable oils

Mineral oil not recommended for drug formulations. Water-miscible, non-volatile liquids

Low molecular weight PEG's Nonionic surfactants such as polysorbate 80

Limitations of liquid contents Water can not exceed 5% of contents pH must be between 2.5 and 7.5

Low molecular weight water soluble and volatile compounds must beexcluded Aldehydes, in general, must be excluded (Cause cross-linking) Contents must flow under gravity at < 35C



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Excipientes Basf Pharma: http://www.basf-pharma.com/ Beghin-Say: http://www.beghin-say.fr/pharmafr/ Borculo Domo Ingredients: http://www.borculodomo.com/milk/lactosaesp/ Brenntag NV: http://www.brenntag.be/

Colorcon: http://www.colorcon.com/ Degussa Pharma: http://www.degussa4pharma.com/http://www.aerosil.com

DMV International: http://www.dmv-international.com/default.asp FMC Biopolymer: http://www.fmcbiopolymer.com/ Friesland Foods Domo: http://www.domo.nl/ International Specialty Products (ISP): http://www.ispcorp.com/ JRS Pharma: http://www.jrspharma.com/ Merck Farma y Qumica, SA:

http://www.merck.de/servlet/PB/menu/1378040/index.html Meggle Pharma: http://www.meggle-pharma.de/es/

PFormulate: http://www.pformulate.com/ Roquette Pharma: http://www.roquette-pharma.com/

Referencias



Mquinas para dosificacin de cpsulas Axus: http://www.axus.cc/ Bosch: http://www.boschpackaging.com/site/home/index.aspx CapPlus Technologies: http://www.capplustech.com/ Torpac: http://www.torpac.com/filling_machines.htm Karisma Pharma Machines: http://www.karishmapharmamachines.com/ Health Star:

http://images.google.com/imgres?imgurl=http://www.healthstar.net/images/UsedMachines/Large/28352-289-01.jpg

Zhejiang Fuchang Machinery: http://www.chinafuchang.com Maneklal: http://www.maneklalexports.com/English/PharmaMc.htm

Referencias



Documents

08-capsulas