Osmotic Pressure Controlled Drug Delivery System

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Slide 1:

OSMOTIC CONTROLLED DRUG DELIVERY SYSTEM PRESENTED BY- VIKRAMJIT SINGH SANDHU PRESENTED TO- Dr. NAWAZISH ALAM S.B.S COLLEGE OF PHARMACY PATTI 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 1

Osmotic Controlled Drug Delivery System:

Osmotic Controlled Drug Delivery System Definition Procedure Diagram Modifications 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 2

Slide 3:

Osmosis - Movement of solvent from lower to higher concentration. - The passage of solvent into a solution through semipermeable membrane. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 3 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.

Slide 4:

Osmotically Controlled Systems osmotic pressure provides the driving force to generate controlled release of drug . Consider a semipermeable membrane that is permeable to water, but not to drug . When this device is exposed to water or any body fluid, water will flow into the tablet owing to the osmotic pressure difference . 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 4

Osmotic Controlled System:

Osmotic 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, 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 5

Equation:

Equation (Q/t) z = Pw Am/ hm ( π s- π e ) (Q/t)= Rate of zero order drug release. Pw, Am & hm= water permeability, effective surface area & thickness of semipermeable membrane. π s= osmotic pressure of saturated solution of osmotically active drug or salt in system. π e = osmotic pressure of GI fluid. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 6

Slide 7:

Types of Osmotically Controlled Systems Type A contains a osmotic core with drug Type B contains the drug solution in a flexible bag, with the osmotic core surrounding 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 7

Slide 8:

Examples of Osmotic Pump Systems Acutrim  Appetite suppressant Concerta ADHD Procardia Hypertension/angina Volmax Bronchiodilator Ditropan Overactive bladder 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 8

Slide 9:

Osmotic Drug Delivery Devices They fall in two categories 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 9

Slide 10:

Implantable The Rose and Nelson Pump Higuchi Leeper Pump Higuchi Theuwes pump Implantable Miniosmotic pump 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 10

Slide 11:

2. Oral osmotic Pump Single chamber osmotic pump Elementary osmotic pump Multi chamber osmotic pump Push pull osmotic pump Osmotic pump with non expanding second chamber 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 11

Slide 12:

Specific types Controlled porosity osmotic pump Osmotic bursting osmotic pump Liquid OROS Delayed Delivery Osmotic device · Telescopic capsule 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 12

Slide 13:

Oros ct (colon targeting) Sandwiched oral therapeutic system Osmotic pump for insoluble drugs Monolithic osmotic systems OSMAT 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 13

Slide 14:

Elementary Osmotic Pump The elementary osmotic pump is a new delivery system for drugs. It delivers the agent by an osmotic process at a controlled rate. Control resides in the : A) Water permeation characteristics of a semi permeable membrane surrounding the formulating agent b) Osmotic properties of the formulation 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 14

Osmotic Pressure Controlled System:

Osmotic Pressure Controlled System 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 15

Slide 16:

These system are suitable or delivery of drugs having moderate water solubility. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 16

Slide 17:

Push Pull Osmotic Pump Push pull osmotic pump is a modified EOP. through, which it is possible to deliver both poorly water-soluble and highly water soluble drugs at a constant rate. This system resembles a standard bilayer coated tablet. One layer (depict as the upper layer) contains drug in a formulation of polymeric, osmotic agent and other tablet excipients . This polymeric osmotic agent has the ability to form a suspension of drug in situ. When this tablet later imbibes water, the other layer contains osmotic and colouring agents, polymer and tablet excipients 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 17

Slide 18:

Liquid Oral Osmotic System Liquid OROS are designed to deliver drugs as liquid formulations and combine the benefits of extended release with high bioavailability. They are of three types: - L OROS hard cap, L OROS soft cap 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 18

Osmotic Pressure Controlled System:

Osmotic Pressure Controlled System 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 19

Slide 20:

Advantage Osmotic drug delivery system for oral and parenteral use offer distinct and practical advantage over other means of delivery. The following advantages contributed to the popularity of osmotic drug delivery system. 1. They   typically give a zero order release profile after an initial lag. 2. Deliveries may be delayed or pulsed if desired. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 20

Slide 21:

3. Drug release is independent of gastric pH and hydrodynamic condition. 4.They are well characterized and understood. 5. The release mechanisms are not dependent on drug. 6. A high degree of in-vitro and in vivo correlation 7. The rationale for this approach is that the presence of water in g.i.t . is relatively constant, at least in terms of the amount required for activation and controlling osmotically base technologies. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 21

Slide 22:

Disadvantage 1 Costly 2 . If the coating process is not well controlled there is a risk of film defects, which    results in dose dumping 3 . Size hole is critical 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 22

Slide 23:

Basic Component Of Osmotic Pumps 1 . Drug 2 . Osmotic agent 3 . Semi permeable membrane 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 23

Slide 24:

Drugs Short biological half-life {2-6h} Highly potent drug Required for prolonged treatment e.g . nifedipine , glipizide , virapamil . 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 24

Slide 25:

Osmotic agents Osmogents used for fabrication of osmotic dispensing device are inorganic or organic in nature a water soluble drug by it self can serve the purpose of an osmogent Inorganic water-soluble osmogents Magnesium sulphate Sodium chloride Sodium sulphate Potassium chloride Sodium bicarbonate 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 25

Slide 26:

Organic polymer osmogents Sodium carboxymethyl cellulose Hydroxypropylmethyl cellulose Hydroxyethylmethylcellulose Methylcellulose Polyethylene oxide Polyvinyl pyrollidine 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 26

Slide 27:

Semi Permeable Membrane The semi permeable membrane should be a stable both to the outer inner environment of the device. The membrane must be sufficiently rigid so as to retain its dimensional integrity during the operational lifetime of the device. The membrane should also be relatively impermeable to the contents of dispenser so that osmogent is not lost by diffusion across the membrane finally, the membrane must be biocompatible Ideal Property of Semi Permeable Membrane The Semi Permeable Membrane must meet some performance criteria 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 27

Slide 28:

1. The material must posses sufficient wet strength (-10 5 ) and wet modulus so as to retain its dimensional integrity during the operational lifetime of the device. 2. The membrane exhibit sufficient water permeability so as to retain water flux rate in the desired range. The water vapor transmission rates can be used to estimate water flux rates 3. The reflection coefficient and leakiness of the osmotic agent should approach the limiting value of unity. Unfortunately, polymer membranes that are more permeable to water are also, in general more permeable to the osmotic agent. 4. The membrane should also be biocompatible 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 28

Modifications:

Modifications - Immediate release system. - Osmotically active compartment system 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 29

Immediate Release 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. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 30

Osmotically active system:

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. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 31 Movable partition Delivery orifice Osmotically active compartment Drug compartment

Some Popular Brand names used for OCDDS:

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 ) 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 32

Some Examples of OCDDS:

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) 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 33

Recent Trends : Extended release formulation of Bupropion:

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. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 34

Recent Trends : Extended release formulation of Bupropion:

Recent Trends : Extended release formulation of Bupropion 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 35

Recent Trends: OROS Technology (ALZA corporation):

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) 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 36 ELEMENTARY OSMOTIC PUMP

References:

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 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 37

Slide 38:

Thank you for listening me……… 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 38

Questions?:

Questions? 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 39