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Contents
 Overview of Digestive system
 Introduction
 Advantages
 Disadvantages
 Mechanisms
1.Dissolution
2.Diffusion
3.Combination of Dissolution & Diffusion
4.Osmotic pressure controlled system
 References
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 2
 Patient comfort and compliance
 Therapeutic advantage
 Reduction in adverse side effects and improvement in
tolerability
 Reduction in healthcare cost
 Maximum utilization of drug enabling reduction in total
amount of dose administered
WHY CONTROLLED RELEASE
Concept
 Controlled drug delivery is one which
delivers the drug at a predetermined rate,
for locally or systemically, for a specified
period of time.
 Continuous oral delivery of drugs at
predictable & reproducible kinetics for
predetermined period throughout the
course of GIT.
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 4
Plasma concentration time profile
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 5
Challenges in Oral
Drug Delivery
 Development of drug delivery system
Delivering a drug at therapeutically effective rate to
desirable site.
 Modulation of GI transit time
Transportation of drug to target site.
 Minimization of first pass elimination
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 6
Advantages
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 7
 Total dose is low.
 Reduced GI side effects.
 Reduced dosing frequency.
 Better patient acceptance and compliance.
 Less fluctuation at plasma drug levels.
 More uniform drug effect
 Improved efficacy/safety ratio.
Disadvantages
 Dose dumping.
 Reduced potential for accurate dose adjustment.
 Need of additional patient education.
 Stability problem.
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 8
Mechanism aspects of Oral drug
delivery formulation
1.Dissolution : 1.Matrix
2.Encapsulation
2.Diffusion : 1.Matrix
2.Reservoir
3.Combination of both dissolution & diffusion.
4.Osmotic pressure controlled system
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 9
Dissolution Definition:
 Solid substances solubilizes in a given
solvent.
 Mass transfer from solid to liquid.
 Rate determining step: Diffusion from solid
to liquid.
 Several theories to explain dissolution –
Diffusion layer theory (imp)
Surface renewal theory
Limited solvation theory.
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 10
Noyes Whitney Equation
dc/dt = kD.A (Cs – C )
dc/dt = D/h A. (Cs – C)
dc/dt = Dissolution rate.
k= Dissolution rate constant (1st order).
D = Diffusion coefficient/diffusivity
Cs = Saturation/ maximum drug solubility.
C =Con. Of drug in bulk solution.
Cs-C=concentration gradient.
h =Thickness of diffusion layer.
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 11
Matrix Type
 Also called as Monolith dissolution
controlled system.
 Controlled dissolution by:
1.Altering porosity of tablet.
2.Decreasing its wettebility.
3.Dissolving at slower rate.
 First order drug release.
 Drug release determined by dissolution
rate of polymer.
 Examples: Dimetane extencaps,
Dimetapp extentabs.
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 12
Soluble drug
Slowly
dissolving
matrix
Encapsulation
 Called as Coating dissolution
controlled system.
 Dissolution rate of coat depends
upon stability & thickness of coating.
 Masks colour,odour,taste,minimising
GI irritation.
 One of the microencapsulation
method is used.
 Examples: Ornade spansules,
Chlortrimeton Repetabs
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 13
Soluble drug
Slowly
dissolving or
erodible
coat
Diffusion
 Major process for absorption.
 No energy required.
 Drug molecules diffuse from a region of higher concentration to
lower concentration until equilibrium is attainded.
 Directly proportional to the concentration gradient across the
membrane.
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 14
Matrix Diffusion Types
 Rigid Matrix Diffusion
Materials used are insoluble plastics such as PVP & fatty
acids.
 Swellable Matrix Diffusion
1. Also called as Glassy hydrogels.Popular for sustaining
the release of highly water soluble drugs.
2. Materials used are hydrophilic gums.
Examples : Natural- Guar gum,Tragacanth.
Semisynthetic -HPMC,CMC,Xanthum gum.
Synthetic -Polyacrilamides.
Examples: Glucotrol XL, Procardia XL
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 15
Matrix system
Rate controlling
step:
Diffusion of dissolved
drug in matrix.
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 16
Higuchi Equation
Q = DE/T (2A.E Cs)Cs.t)1/2
Where ,
Q=amt of drug release per unit surface area at time t.
D=diffusion coefficient of drug in the release medium.
E=porosity of matrix.
Cs=solubility of drug in release medium.
T=tortuosity of matrix.
A=concentration of drug present in matrix per unit
volume.
17
Reservoir System
 Also called as Laminated matrix device.
 Hollow system containing an inner core surrounded in
water insoluble membrane.
 Polymer can be applied by coating or micro
encapsulation.
 Rate controlling mechanism - partitioning into
membrane with subsequent release into surrounding
fluid by diffusion.
 Commonly used polymers - HPC, ethyl cellulose &
polyvinyl acetate.
 Examples: Nico-400, Nitro-Bid
18
Reservoir System Rate controlling
steps :
Polymeric content in
coating, thickness of
coating, hardness of
microcapsule.
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 19
Dissolution & Diffusion Controlled
Release system
 Drug encased in a partially soluble
membrane.
 Pores are created due to dissolution
of parts of membrane.
 It permits entry of aqueous medium
into core & drug dissolution.
 Diffusion of dissolved drug out of
system.
 Ex- Ethyl cellulose & PVP mixture
dissolves in water & create pores of
insoluble ethyl cellulose membrane.
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 20
Insoluble
membrane
Pore created by
dissolution of soluble
fraction of
membrane
Entry of
dissolution
fluid
Drug
diffusion
Osmotic Pressure Controlled Drug
Delivery System
 Definition
 Procedure
 Diagram
 Modifications
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 21
Osmosis
- Movement of solvent from lower to higher concentration.
- The passage of solvent into a solution through
semipermeable membrane.
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 22
Semipermeable Membrane
Molecules are permitted only to one component (Water).
Osmotic pressure
It is the hydrostatic pressure produced by a solution in a space
divided by a semipermeable membrane due to difference in
concentration of solutes.
Osmotic Pressure Controlled
System
 Provides zero order release
 Drug may be osmotically active, or combined with an
osmotically active salt (e.g., NaCl).
 Semipermeable membrane usually made from cellulose
acetate.
 More suitable for hydrophilic drug.
 Examples: Glucotrol XL, Procardia XL,
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 23
Equation
(Q/t) z = Pw Am/ hm (πs-πe )
(Q/t)= Rate of zero order drug release.
Pw, Am & hm= water permeability, effective surface
area & thickness of semipermeable membrane.
πs= osmotic pressure of saturated solution of
osmotically active drug or salt in system.
πe = osmotic pressure of GI fluid.
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 24
Osmotic Pressure Controlled
System
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 25
Osmotic Pressure Controlled
System
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 26
- Immediate release system.
- Osmotically active compartment system
Immediate Release System
 Activation of system is done.
 Dividing a dose into two parts.
 One third immediate release.
 Two third controlled release.
 Encapsulated into semipermeable
membrane.
e.g. : Phenyl propanolamine.
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 28
Osmotically active system
 Two compartments
separated by movable
partition.
 Osmotically active
compartment absorbs
water from GIT.
 Creates osmotic
pressure.
 Partition moves upward
& then drug releases.
 Ex: Nifedipine.
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 29
Movable
partition
Delivery orifice
Osmotically active
compartment
Drug compartment
Some Popular Brand names used
for OCDDS
 Spansule capsule ( SK & F )
 Sequal capsule (Lederle )
 Extentab tablets ( Robins )
 Timespan tablet ( Roche )
 Dospan tablet ( Merrell Dow )
 Chronotab tablet ( Schering )
 Plateau capsule ( Marion )
 Tempule capsule ( Armour )
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 30
Some Examples of OCDDS
 Propranolol (Inderal LA)
 Methyiphenidate HCl (RitalinSR)
 Iron (Slow-Fe)
 GITS-Prazosin (Minipress)
 Morphine sulfate (Roxanol SR)
 Decongestant & antihistamine (Resaid SR, Novafed SR
Dristan)
 Pseudoephedrine HCI (Sudafed SA)
 Potassium (Micro-K, Slow-K, Klotrix)
 Antitussive combinations (Rescap, Ornade Spansules)
 Chlorpheniramine maleate (ChlorTrimeton)
 Decongestant, antihistamine and anticholinergic (Dallergy,
Supres)
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 31
Recent Trends : Extended release formulation of
Bupropion
 Bupropion is used in the treatment of major depressive
disorder.
 Conventional formulation has to be administered 3 times
daily
 Initially 150 mg ER formulation was introduced for bid
regimen
Later on 300 mg ER formulation was introduced for once
daily regimen
 For ER formulation provide similar Cmax and AUC values
as compared to immediate release formulation at steady
state.
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 32
Recent Trends : Extended release formulation of
Bupropion
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 33
Recent Trends: OROS Technology (ALZA
corporation)
 Single layer tablet: Drug
core (water soluble drug
with or without excipients)
 Semipermeable membrane
with a drilled orifice
 Water imbibition by the core
because of osmotic action
results in drug dissolution,
which is released at a
controlled rate through the
orifice
 Not suitable for water insoluble drugs.
 Examples: Sudafed 24
hours (Pseudoephedrine); Volmax (Salbutamol)
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 34
ELEMENTARY OSMOTIC PUMP
Recent trends: Geomatrix® (SKY Parma)
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 35
This technology Controls amount,
timing and location of release in body.
-Formulation with predictable and
reproducible drug release profile.
-Controls rate of drug diffusion
throughout release process,
ensuring 100% release Products
Products in market:
Cordicant -uno®
Madopar DR
SULAR ER
Coating technology using various polymers for coating
tablets and granules
Matrix systems made of swellable or nonswellable
polymers
Slowly eroding devices
Osmotically controlled devices.
CURRENTLY MARKECONTROLLED-
RELEASE SYSTEMSTED ORAL
Oral CR
60%
Implant
10%
Inhalation
27%
Transdermal
8%
All Other
2%
US Drug Delivery Market
“Drug delivery market dominated by oral delivery systems”
Source: IMS America - Drug delivery based products
Particulate systems
Chronopharmacokinetic systems
Targeted drug delivery
Mucoadhesive delivery
THE FUTURE
Thank you for listening me………
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 39
References
 Novel drug delivery system , volume 50,
Y.W.Chien
 The theory & practice of industrial pharmacy,
Leon Lachman , Herbert A.Lieberman,
Joseph L.Kanig,3 rd edition.
 The Eastern pharmacist, november 1993.
Sustained release drugs, V R.Gudsoorkar & D.Rambhau
page 27-32
 Biopharmaceuitics & pharmacokinetics,
D M.Brahmankar & Sunil B. Jaiswal.
www.google.com
31/12/2009 Nepal Pharmaceutical Ltd., Nepal 40

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controlled oral.pptx

  • 1.
  • 2. Contents  Overview of Digestive system  Introduction  Advantages  Disadvantages  Mechanisms 1.Dissolution 2.Diffusion 3.Combination of Dissolution & Diffusion 4.Osmotic pressure controlled system  References 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 2
  • 3.  Patient comfort and compliance  Therapeutic advantage  Reduction in adverse side effects and improvement in tolerability  Reduction in healthcare cost  Maximum utilization of drug enabling reduction in total amount of dose administered WHY CONTROLLED RELEASE
  • 4. Concept  Controlled drug delivery is one which delivers the drug at a predetermined rate, for locally or systemically, for a specified period of time.  Continuous oral delivery of drugs at predictable & reproducible kinetics for predetermined period throughout the course of GIT. 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 4
  • 5. Plasma concentration time profile 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 5
  • 6. Challenges in Oral Drug Delivery  Development of drug delivery system Delivering a drug at therapeutically effective rate to desirable site.  Modulation of GI transit time Transportation of drug to target site.  Minimization of first pass elimination 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 6
  • 7. Advantages 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 7  Total dose is low.  Reduced GI side effects.  Reduced dosing frequency.  Better patient acceptance and compliance.  Less fluctuation at plasma drug levels.  More uniform drug effect  Improved efficacy/safety ratio.
  • 8. Disadvantages  Dose dumping.  Reduced potential for accurate dose adjustment.  Need of additional patient education.  Stability problem. 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 8
  • 9. Mechanism aspects of Oral drug delivery formulation 1.Dissolution : 1.Matrix 2.Encapsulation 2.Diffusion : 1.Matrix 2.Reservoir 3.Combination of both dissolution & diffusion. 4.Osmotic pressure controlled system 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 9
  • 10. Dissolution Definition:  Solid substances solubilizes in a given solvent.  Mass transfer from solid to liquid.  Rate determining step: Diffusion from solid to liquid.  Several theories to explain dissolution – Diffusion layer theory (imp) Surface renewal theory Limited solvation theory. 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 10
  • 11. Noyes Whitney Equation dc/dt = kD.A (Cs – C ) dc/dt = D/h A. (Cs – C) dc/dt = Dissolution rate. k= Dissolution rate constant (1st order). D = Diffusion coefficient/diffusivity Cs = Saturation/ maximum drug solubility. C =Con. Of drug in bulk solution. Cs-C=concentration gradient. h =Thickness of diffusion layer. 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 11
  • 12. Matrix Type  Also called as Monolith dissolution controlled system.  Controlled dissolution by: 1.Altering porosity of tablet. 2.Decreasing its wettebility. 3.Dissolving at slower rate.  First order drug release.  Drug release determined by dissolution rate of polymer.  Examples: Dimetane extencaps, Dimetapp extentabs. 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 12 Soluble drug Slowly dissolving matrix
  • 13. Encapsulation  Called as Coating dissolution controlled system.  Dissolution rate of coat depends upon stability & thickness of coating.  Masks colour,odour,taste,minimising GI irritation.  One of the microencapsulation method is used.  Examples: Ornade spansules, Chlortrimeton Repetabs 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 13 Soluble drug Slowly dissolving or erodible coat
  • 14. Diffusion  Major process for absorption.  No energy required.  Drug molecules diffuse from a region of higher concentration to lower concentration until equilibrium is attainded.  Directly proportional to the concentration gradient across the membrane. 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 14
  • 15. Matrix Diffusion Types  Rigid Matrix Diffusion Materials used are insoluble plastics such as PVP & fatty acids.  Swellable Matrix Diffusion 1. Also called as Glassy hydrogels.Popular for sustaining the release of highly water soluble drugs. 2. Materials used are hydrophilic gums. Examples : Natural- Guar gum,Tragacanth. Semisynthetic -HPMC,CMC,Xanthum gum. Synthetic -Polyacrilamides. Examples: Glucotrol XL, Procardia XL 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 15
  • 16. Matrix system Rate controlling step: Diffusion of dissolved drug in matrix. 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 16
  • 17. Higuchi Equation Q = DE/T (2A.E Cs)Cs.t)1/2 Where , Q=amt of drug release per unit surface area at time t. D=diffusion coefficient of drug in the release medium. E=porosity of matrix. Cs=solubility of drug in release medium. T=tortuosity of matrix. A=concentration of drug present in matrix per unit volume. 17
  • 18. Reservoir System  Also called as Laminated matrix device.  Hollow system containing an inner core surrounded in water insoluble membrane.  Polymer can be applied by coating or micro encapsulation.  Rate controlling mechanism - partitioning into membrane with subsequent release into surrounding fluid by diffusion.  Commonly used polymers - HPC, ethyl cellulose & polyvinyl acetate.  Examples: Nico-400, Nitro-Bid 18
  • 19. Reservoir System Rate controlling steps : Polymeric content in coating, thickness of coating, hardness of microcapsule. 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 19
  • 20. Dissolution & Diffusion Controlled Release system  Drug encased in a partially soluble membrane.  Pores are created due to dissolution of parts of membrane.  It permits entry of aqueous medium into core & drug dissolution.  Diffusion of dissolved drug out of system.  Ex- Ethyl cellulose & PVP mixture dissolves in water & create pores of insoluble ethyl cellulose membrane. 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 20 Insoluble membrane Pore created by dissolution of soluble fraction of membrane Entry of dissolution fluid Drug diffusion
  • 21. Osmotic Pressure Controlled Drug Delivery System  Definition  Procedure  Diagram  Modifications 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 21
  • 22. Osmosis - Movement of solvent from lower to higher concentration. - The passage of solvent into a solution through semipermeable membrane. 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 22 Semipermeable Membrane Molecules are permitted only to one component (Water). Osmotic pressure It is the hydrostatic pressure produced by a solution in a space divided by a semipermeable membrane due to difference in concentration of solutes.
  • 23. Osmotic Pressure Controlled System  Provides zero order release  Drug may be osmotically active, or combined with an osmotically active salt (e.g., NaCl).  Semipermeable membrane usually made from cellulose acetate.  More suitable for hydrophilic drug.  Examples: Glucotrol XL, Procardia XL, 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 23
  • 24. Equation (Q/t) z = Pw Am/ hm (πs-πe ) (Q/t)= Rate of zero order drug release. Pw, Am & hm= water permeability, effective surface area & thickness of semipermeable membrane. πs= osmotic pressure of saturated solution of osmotically active drug or salt in system. πe = osmotic pressure of GI fluid. 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 24
  • 25. Osmotic Pressure Controlled System 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 25
  • 26. Osmotic Pressure Controlled System 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 26
  • 27. - Immediate release system. - Osmotically active compartment system
  • 28. Immediate Release System  Activation of system is done.  Dividing a dose into two parts.  One third immediate release.  Two third controlled release.  Encapsulated into semipermeable membrane. e.g. : Phenyl propanolamine. 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 28
  • 29. Osmotically active system  Two compartments separated by movable partition.  Osmotically active compartment absorbs water from GIT.  Creates osmotic pressure.  Partition moves upward & then drug releases.  Ex: Nifedipine. 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 29 Movable partition Delivery orifice Osmotically active compartment Drug compartment
  • 30. Some Popular Brand names used for OCDDS  Spansule capsule ( SK & F )  Sequal capsule (Lederle )  Extentab tablets ( Robins )  Timespan tablet ( Roche )  Dospan tablet ( Merrell Dow )  Chronotab tablet ( Schering )  Plateau capsule ( Marion )  Tempule capsule ( Armour ) 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 30
  • 31. Some Examples of OCDDS  Propranolol (Inderal LA)  Methyiphenidate HCl (RitalinSR)  Iron (Slow-Fe)  GITS-Prazosin (Minipress)  Morphine sulfate (Roxanol SR)  Decongestant & antihistamine (Resaid SR, Novafed SR Dristan)  Pseudoephedrine HCI (Sudafed SA)  Potassium (Micro-K, Slow-K, Klotrix)  Antitussive combinations (Rescap, Ornade Spansules)  Chlorpheniramine maleate (ChlorTrimeton)  Decongestant, antihistamine and anticholinergic (Dallergy, Supres) 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 31
  • 32. Recent Trends : Extended release formulation of Bupropion  Bupropion is used in the treatment of major depressive disorder.  Conventional formulation has to be administered 3 times daily  Initially 150 mg ER formulation was introduced for bid regimen Later on 300 mg ER formulation was introduced for once daily regimen  For ER formulation provide similar Cmax and AUC values as compared to immediate release formulation at steady state. 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 32
  • 33. Recent Trends : Extended release formulation of Bupropion 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 33
  • 34. Recent Trends: OROS Technology (ALZA corporation)  Single layer tablet: Drug core (water soluble drug with or without excipients)  Semipermeable membrane with a drilled orifice  Water imbibition by the core because of osmotic action results in drug dissolution, which is released at a controlled rate through the orifice  Not suitable for water insoluble drugs.  Examples: Sudafed 24 hours (Pseudoephedrine); Volmax (Salbutamol) 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 34 ELEMENTARY OSMOTIC PUMP
  • 35. Recent trends: Geomatrix® (SKY Parma) 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 35 This technology Controls amount, timing and location of release in body. -Formulation with predictable and reproducible drug release profile. -Controls rate of drug diffusion throughout release process, ensuring 100% release Products Products in market: Cordicant -uno® Madopar DR SULAR ER
  • 36. Coating technology using various polymers for coating tablets and granules Matrix systems made of swellable or nonswellable polymers Slowly eroding devices Osmotically controlled devices. CURRENTLY MARKECONTROLLED- RELEASE SYSTEMSTED ORAL
  • 37. Oral CR 60% Implant 10% Inhalation 27% Transdermal 8% All Other 2% US Drug Delivery Market “Drug delivery market dominated by oral delivery systems” Source: IMS America - Drug delivery based products
  • 38. Particulate systems Chronopharmacokinetic systems Targeted drug delivery Mucoadhesive delivery THE FUTURE
  • 39. Thank you for listening me……… 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 39
  • 40. References  Novel drug delivery system , volume 50, Y.W.Chien  The theory & practice of industrial pharmacy, Leon Lachman , Herbert A.Lieberman, Joseph L.Kanig,3 rd edition.  The Eastern pharmacist, november 1993. Sustained release drugs, V R.Gudsoorkar & D.Rambhau page 27-32  Biopharmaceuitics & pharmacokinetics, D M.Brahmankar & Sunil B. Jaiswal. www.google.com 31/12/2009 Nepal Pharmaceutical Ltd., Nepal 40