innovation in capsule dosage form. l ist of contents - introduction innovations in capsules 1....
TRANSCRIPT
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INNOVATION IN CAPSULE DOSAGE FORM
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LIST OF CONTENTS -
Introduction Innovations in capsules
1 . Innovation in capsule shells
2 . Innovation in capsule system Newer technologies Current research Reference
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MAINLY TWO TYPES
1. HARD GELATIN CAPSULE 2. SOFT GELATIN CAPSULE
Some of the innovations are targeted to: Overcome the disadvantages associated with
conventional capsules. Achieve modified drug release. Encapsulation of various kind of material. Modified applications
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Capsules are use for filling different materials like
Powder Granules Beads
PastesCapletsTablets
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INNOVATIONS IN CAPSULES: Innovations in Capsule Shells: it includes
modification of capsule shell to improve shell property.
Improvement in the shell property Provide physical strength Protection from moisture Protection from microbial contamination Protection from light and oxygen Improve compatibility of fill material with capsule shell
Innovations in Capsule System: it includes modification of the system to achieve modified release.
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1 INNOVATIONS IN CAPSULE SHELLS:
IT INCLUDES:
Non animal Capsule Animal Capsule
HPMC Capsules Gelatine/ PEG Capsules Pullulan Capsules Coni-Snap®
Capsule(OceanCaps) PVA Capsule Press-fit® Gelcaps Starch Capsule LiCaps® V Caps® Posilock Minicapsule
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1. NON-ANIMAL CAPSULE SHELL
A. HPMC CAPSULES(HYPROMELLOSE):
Hypromellose as a release controlling polymer with diffusion and erosion controlled release
Features :• Chemically stable.• Low moisture content than Gelatin capsule, Less brittle • Fast dissolution • Lower water vapor permeability than Gelatin capsule.
(Gelatin>PEG-Gelatin>HPMC)• High tolerance to temperature • Chemical inactivity
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QUALI-V®-I: A New Key for Dry Powder Inhalers
Superior physical performance a moisture content.
Content could easily arises in the usage of DPI with capsules.
Better cutting & puncturing performance. Elimination of the generation of shell
particles in use.
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B. PULLULAN CAPSULES:Pullulan is a neutral glucan (like Amylose, Dextran,Cellulose)
Water-soluble polysaccharide • Derived by bacterial fermentation from corn.• odorless, tasteless, and completely biodegradable .• Dried capsules are comparatively weak in physical strength • Requires water to act as a film plasticizer, which may have a negative
effect on active ingredients.
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NP CapsTM: Made up of pullalan.
Pullulan is very stable and well-characterized, and has achieved wide regulatory acceptance with its proven safety record.
No chemical modification, Starch-free, Preservative-free, Gluten-free.
C. PVA CAPSULES:Insoluble drugs can be dissolved in solvents such as
macrogol 400, being filled in capsules. The bioavailability of insoluble drugs can be improved
very much. E.g. PONDAC Capsule (name)
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D. STARCH CAPSULES: Manufactured by the injection moulding technique developed by Capsugel
(Capill®). Sealing is achieved by applying a hydro alcoholic solution to inner section of
the cap, immediately prior to its being placed on to the body.
Offers advantages like. pH independent dissolution Suitable for enteric coating Tamper evident
Enteric starch -Coating of starch capsules appear to be less problematic becoz of the
smooth seal, coupled with the higher bulk densityof the capsules, which provides for s more uniform coating bed.
VCaps®:
Two-piece capsules made from cellulosic raw materials
Vcaps capsules are also starch-free, gluten-free and preservative-free
Easy to swallowEffectively mask taste & odor
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2. ANIMAL CAPSULE SHELL
A. Ocean CapsTM: It contain all-natural marine supplements Ideally suited for fish-eating vegetarians looking for
fish capsules, and marine supplements such as fish oil, DHA, salmon liver oil, shark cartilage, glucosamine iron,zinc, calcium and vitamins B2 and B12 .
B. PRESS FIT® GELCAPS: consisting of a high-gloss gelatin coating that encases
a caplet core.
Manufactured by exclusive cold- shrink process Press-fit gelcaps combine the best qualities of a
gelatin capsules with the density of a tablet, creating an exciting new dosage form that can be custom engineered to meet specific product performance criteria.
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C. LICAPS®: specially designed to be sealed for secure containment of
liquids and semi-solids. They may be filled at temperatures up to 70° C.
D. POSILOK®: The locking system used by Qualicaps. It ensures that the contents reach the consumer intact, and
are protected at all times from external contamination.
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E. GELATIN/PEG CAPSULES: Reduce the brittleness of standard gelatin
capsules when exposed to a low-moisture content thus making the capsules more compatible to hygroscopic formulations or moisture-sensitive ingredients
At moisture content b/w 8-12 %, gelatin / PEG capsules have equivalent mechanical strength to standard capsules with moisture b/w 13-16 %.
Gelatin/PEG Features Less brittle Good for hygroscopic formulations Good for moisture-sensitive ingredients Odorless, tasteless Three-year shelf life
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MINICAPSULES (SIZE 9) Minicapsule dimensional specifications Minicapsules are available in both gelatin and
hypromellose (HPMC) options.
CAPACITY25 mm3
CAP LENGTH 4.3 mm +/- 0.30 mm
BODY LENGTH 7.3 mm +/- 0.30 mm
CAP DIAMETER 2.65 mm +/- 0.10 mm
BODY DIAMETER 2.40 mm +/- 0.10 mm
CLOSED JOINED LENGTH
8.40 mm +/- 0.30 mm
WEIGHT 9.5 mg +/- 2 mg
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INNOVATIONS IN CAPSULE SYSTEM:To provide modified release :
PORT CAPSULE TECHNOLOGY: HYDROPHILIC SANDWICH (HS) CAPSULE L-OROS® PULSINCAP CHEWABLE SOFT GELATIN CAPSULE
ENCAPSULATING LIQUID FILL INNERCAP TECHNOLOGY GALACTICLES
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1. PORT CAPSULE TECHNOLOGY:eg.Pseudoephedrine delayed release
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2 . HYDROPHILIC SANDWHICH(HS) CAPSULES: time delayed probe capsule , This effectively created a “
Hydrophilic Sandwich “ between two gelatin capsule .
When the outer capsule dissolved, the sandwich of HPMC formed a gel barrier layer that provided a time delay before fluid could enter the inner capsule and cause drug release
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3. L-OROS®:
Controlled Release of Non-Aqueous Liquid Formulation L-OROS Hard cap L-OROS Soft cap Delayed liquid bolus delivery systemconsists of liquid drug, an osmotic engine or push
layer and a semi permeable membrane coating ◦Advantages:
Enhanced bioavailability of class II drugs Uniform blood levels over specific period of time Reduced first pass effect Reduced dose Patient compliance Made of pharmaceutical acceptable excipient
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1.L-OROS HARD CAP:
The drug layer and the osmotic engine are encased in hard capsule which is surrounded by the rate controlling semi permeable membrane.A barrier layer composed of an inert substance separates the drug layer from osmotic engine.A delivery orifice is laser drilled at the opposite end of the osmotic engine providing an outlet for the drug.
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•The liquid drug formulation is encased in soft capsule. It is in turn surrounded by a barrier layer, osmotic engine, and a semi permeable membrane in order.•A delivery orifice in drilled through semi-permeable membrane,osmotic engine and barrier layer.
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DELAYED LIQUID BOLUS SYSTEM:
Delivers the pulse of the liquid drug.The system consists of the placebo delay layer, a liquid drug layer, an osmotic engine all encased by a subcoat and then surrounded by semi-permeable membrane.
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4. Innercap technology
The combination example consists of a high potency insoluble active in a lipid emulsion, sustained release tablet and a cocktail of two crystalline active materials.
A combination of release profiles can be incorporated in the system.
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FINISHED INNERCAP
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5. PULSIN CAP:Used for pulsatile drug delivery.consists of insoluble capsule body and a soluble
capsule cap.
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GalacticlesTM Oral Lipid Matrix in Liquid-Filled Softgel Capsules: A Novel Drug Delivery System for Improved Oral Bioavailability & improve the formulation of poorly soluble drugs, administered in liquid-filled softgel capsules.
(Drug development & delivery Issue Date: Vol. 2 No. 7 October 2002)
50% neutral lipids (mono-, di-, and tri-glycerides), and 50% polar lipids (mixed galactolipids and phospholipids, 70:30) called galactolecithin
6. GalacticlesTM
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NEWER TECHNOLOGIES :
1. ORBEXA® TECHNOLOGY:
It produces beads that are of controlled size and density and suitable for formulation as controlled release multiparticulates - using granulation, spheronization and extrusion technique.
The resultant beads can be coated with functional polymer membrane for additional release rate control and may be filled into capsules
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Advantages of Orbexa Aqueous or solvent-based granulation High-speed process is well suited for
sensitive molecules like proteins Suitable for high drug loading
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2. EURAND MINITABS® TECHNOLOGY: Eurand's microencapsulated drugs can be taste-
masked and directly compressed with Advatab to ensure an optimised drug delivery process.Microcaps® - microencapsulation of drug particles via a proprietary coacervation technique for uniform, precise taste-masking
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3. SODAS® TECHNOLOGY:
SODAS® (Spheroidal Oral Drug Absorption System) is particulate drug delivery system.
SODAS® Technology is based on the production of uniform spherical beads of 1-2mm in diameter containing drug plus excipients and coated with product specific controlled release polymers.
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4. CODAS® TECHNOLOGY: Chronotherapeutic Oral Drug Absorption
System(CODASTM Technology) was developed to achieve this prolonged interval.
Delay is introduced by the level of release controlling polymer applied to the drug loaded beads. The release controlling polymer is a combination of water soluble and water insoluble polymers.
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As water from the GIT contacts the polymer coat beads, the water soluble polymer slowly dissolves and the drug diffuses through the resulting pores in the coating.
The water insoluble polymer continues to act as a barrier, maintaining the controlled release of the drug.
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5. PRODAS® TECHNOLOGY:
which is unique in that it combines the benefits of tabletting technology within a capsule.
It can be used to pre-program the release rate of a drug.
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PRODAS® technology, by incorporating minitablets with different release rates, can display the characteristics of a number of different conventional dosage forms:
delayed release component for site/regional release and/or food resistance
sustained release component for additional controlled release/profile extension
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6. BANNER’S VERSETROLTM TECHNOLOGY:
Drug is incorporated in lipophilic or hydrophilic matrix and that is than incorporated in soft gelatin capsule shell.
7. Bijel Capsules: Co-release Micro-gel
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new generic route to gel capsule formulation, involving particles suspended in fluid-bicontinuous mixture of two solvents.
The bijel capsules are made of two fluids and hence they are both a gel and an emulsion. The water and oil domains inside the capsules can be used to deliver chemically different active ingredients. The capsules can be designed to release or mix the active ingredients in response to a specific external stimulus.
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Chewable SGC require mixture of gelatin having different bloom values.
Most preferable combination ration : 3:1 to 5:1 It contains ingredients like,
Low bloom gelatin Medium bloom gelatin Placticizers Water Moisture retaining agent Other
Chewable soft gelatin capsule encapsulating liquid fill
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Jintan Capsule
Mira cell Soft Capsule Hard capsule
APPEARNCE
MANUFACTURING
DROPPING METHODFILLER ROTARY DIE PROCESS DIPPING METHOD
SHELL RATIO
10%~ 30%~ 20~50%
DIAMETER 0.3mm~10mm 5mm~20mm 10mm~21mm
CONTENTLIPOPHILIC
HYDROPHILICPOWDER
LIPOPHILICPOWDER IN SUSPENSION
POWDER
SHELL MATERIAL
GELATINAGAR
NATURAL GELLING SUBSTANCE
GELATINGLYCERIN
GELATINGLYCERIN
SHELL FUNCTION
HEAT RESISTANCEACID RESISTANCE
FREEZING RESISTANCENO FUNCTION NO FUNCTION
CHARACTERISTICS
FUNCTIONS CAN BE ADDED TO THE SHELL.POSSIBLE TO DESIGN
MULTIPLE LAYER CAPSULES
SHELL THICKNESS IS LARGE ENOUGH TO JOINT
TWO PCS OF GELATIN SHEETS.
USE OF GLYCERIN CAN CAUSE BLOCKING.
ONLY AVAILABLE FOR POWDER, NOT
LIQUID AS CONTENT.NO USE FOR SMALL
CAPSULES.
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NifedipineGel-filledCapsule
Procardia (Pratt)Adalat (Bayer)
10 and20 mg/capsule
Glycerin, peppermintoil, PEG, softgelatin capsule
Swallow whole,bite and swallow,or bite and holdsublinguall
10 Approx 2 hr
Drugs and Dosage Forms Used for Oral Transmucosal system
Drug Brand Name Availability Formulation/ Dose/ Onset of Duration of
(Manufacturer) Excipients Directions Action (min) Action
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EXAMPLES OF MARKETED PRODUCTS FORMULATIONSDrug Name
Compound Dosage form Company Indication
Neoral® Cyclosporine Soft gelatin Capsule Novartis ImmuneSuppressant
Norvir® Ritonavir Soft gelatin capsule AbbottLaboratories
HIV antiviral
Fortovase® Saquinavir Soft gelatin capsule Hoffmann-LaRoche
HIV antiviral
Agenerase® Amprenavir Soft gelatin capsule GlaxoSmithkline
HIV antiviral
Convulex® Valproic acid Hard gelatin Capsule Ligand Antiepileptic
Lipirex® Fenofibrate Soft gelatin capsule Genus Antihyperlipoproteinemic
Sandimmune®
Cyclosporine Soft gelatin capsule Pharmacia ImmunoSuppressant
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CURRENT RESEARCH Invitro – invivo evaluation of a novel capsule for colon specific
drug delivery (JPS Vol. 98 No. 08 Aug. 2009 Page no. 2626)
A novel approach to prepare insulin-loaded poly ( lactic –co-glycolic acid microcapsule) (JPS Vol. 98 no.05 May 2009 page no.1712)
Effect of lipophilic compounds on the compatibility of lipid based formulation with HG capsules. (JPS Vol. 99 no.01 Jan 2010 )
The Bilayer floating capsule : A stomach – directed drug delivery system for misoprostol. ( Pharmaceutical research Vol. 9 No.3 1992)
Self micro emulsifying drug delivery system (IJPS Vol-1, Issue-2, 2010)
Self micro emulsifying drug delivery systems are isotropic mixtures of oil, surfactant, co-surfactant and drug with a unique ability to form fine oil in water microemulsion upon mild agitation following dilution with aqueous phase.
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Pulsatile delivery systems: An approach for chronotherapeutic diseases (Year : 2010 | Volume : 1 | Issue : 1 | Page : 55-61)
Marketed technologies such as PULSYS™, CODAS® , TIMERx® , and DIFFUCAPS® follow one of the above mechanisms to render a sigmoidal drug release profile.
Novel iron- polysaccharide multilayered microcapsule for controlled insulin release.
(C.A. vol. 150 no. 22, 2009 page no. 1469)
cholesterol mediated anchoring of enz. Loaded liposomes within disulfide stabilized polymer carrier capsule. (C.A. vol. 150 no. 21 , 2009 page no. 1479)
achieved by non covalently sandwiched the liposomes b/w a tailor made cholesterol modified poly(-lysine) precursor layer & a poly ( methacrylic acid) –co- (cholesteryl methacrylate) capping layer.
COATING METHOD FOR SOFT GELATIN CAPSULES WITH IMPROVED STABILITY .
(Ref: Chemical Abstracts, Vol 151, Number 13, September 28,2009 , Page2156, 297838p)
Adding 10-90% ethanol into mixture of HPMC 20-150parts, Tween80 8.5-25vol parts, Titanium white powder 7.5-25wt parts, Talc powder 7.5-25wt parts, 2%chocolate brown solution, 7.5-25wt parts, castor oil 15-40 vol parts to obtain coating solution, regulating flow rate of coating material at 25-40°C under relative moisture of 20-60%.
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hydrocapsule : A new method for aqueous drug delivery.
(C.A. vol. 149 no. 2 2008 page no. 1479)
development of boron nanocapsule for neutron capture therapy.
(C.A. vol. 150 no. 22, 2009 page no. 1455)
Cross-linked DNA capsules templated on porous calcium carbonate microparticles: (Colloids and Surfaces A: Physicochemical and Engineering Aspects, Volume 356, Issues 1-3, 5 March 2010, Pages 126-133)
first, DNA was adsorbed onto calcium carbonate microparticles, and then the adsorbed DNA was covalently cross-linked with each other by using ethylene glycol diglycidyl ether.
This method has the potential to be used for the preparation of various single-component polymer capsules.
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LIST OF REFERENCE Chemical Abstracts, Vol 151, Number 13,
September 28,2009 , Page no. 2156 JPS Vol. 98 No. 08 Aug. 2009 Page no. 2626 JPS Vol. 98 no.05 May 2009 page no.1712 JPS Vol. 99 no.01 Jan 2010 JPS Vol. 69 no.04 April 2007 page no. 479-488 Pharmaceutical research Vol. 9 No.3 1992 Angewandte Chemie International Edition
Volume 49, Issue 39, pages 6954–6973, September 17, 2010)
IJPS Vol-1, Issue-2, 2010 Drug development & delivery Issue Date: Vol. 2 No.
7 October 2002
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Journal of Pharmaceutics and Cosmetology Vol 1: 2 (2011) page no 56-66
Drug development & delivery Issue Date: Vol. 2 No. 7 October 2002
www. morishita jintan co.ptd http://en.wikipedia.org/wiki/
Encapsulation_(pharmacology) www.innercaps.com www.capsugel.com http://www.emisphere.com http://www.qualicaps.co.jp/ http://www.capstech.com.cn C.A. vol. 150 no. 22, 2009 page no. 1469 C.A. vol. 149 no. 2 2008 C.A. vol. 150 no. 21 , 2009
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Thank you