OSMOTIC Drug Delivery System

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PRESENTED BY:- NAITIK THAKKAR M.PHARM-II ROLL NO-2 GUIDED BY:- HARESH MULANI ASSISTANT PROFESSOR Dharmaj degree pharmacy college : 

PRESENTED BY:- NAITIK THAKKAR M.PHARM-II ROLL NO-2 GUIDED BY:- HARESH MULANI ASSISTANT PROFESSOR Dharmaj degree pharmacy college SEMINAR ON OSMOTIC DRUG DELIVERY SYSTEM 1 NaitikThakkar/ M.Pharm-II / Pharmaceutics

List of Contents : 

List of Contents Osmosis Osmotic Pressure Advantages n Disadvantages Factor affecting drug release rate Property of Drug Types of Osmotic Pumps Evaluation Marketed Products 2 NaitikThakkar/ M.Pharm-II / Pharmaceutics

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Osmosis … refers to the process of movement of solvent molecules from lower solute concentration to higher solute concentration across a semi permeable membrane. OSMOSIS 3 NaitikThakkar/ M.Pharm-II / Pharmaceutics

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4 The force per unit area, or pressure, required to prevent the passage of water through a selectively permeable membrane and into a solution of greater concentration. OSMOTIC PRESSURE NaitikThakkar/ M.Pharm-II / Pharmaceutics

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 6

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 7 Factors affecting release of medicament from Osmotic DDS DELIVERY ORIFACE OSMOTIC PRESSURE MEMBRANE TYPE SOLUBILITY

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 8 Factors affecting drug release rate A. Solubility: Solubility shd be in the desired range to get optimize drug release. The fraction of a drug release with zero order kinetic is given by F (z) = 1 – S Р Where F (z) = fraction release by zero order S = drug solubility in g / cm 3 P = density of core tablet.

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 9 B. Osmotic pressure: The next release-controlling factor that must be optimized is the osmotic pressure between inside the compartment and the external environment. To achieve a constant osmotic pressure is to maintain a saturated solution of osmotic agent in the compartment.

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 10 C. Size of delivery orifice: The typical orifice size in osmotic pumps ranges from 600µ to 1 mm. Methods to create a delivery orifice in the osmotic tablet coating are: Mechanical drill Laser drill Indentation (Modified punches) Use of leachable substances in the semi permeable coating e.g. controlled porosity osmotic pump

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 11 Entry of water in Osmotic DDS depends on nature and type of membrane used for formulation. Example are Cellulose Ester, Cellulose Triacetate, Cellulose Propionate, Cellulose Acetate Butyrate, Ethyl Cellulose and Eudragits. D. Membrane type E. Other level of pore formers incorporated into the wall the drug load in the core

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 12 Property of Drugswhich are used in ODDS Short biological half-life {2-6h} Highly potent drug Required for prolonged treatment e.g. Nifedipine Glipizide Verapamil Chlorpromazine hydrochloride

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 13 Type of Osmotic Pumps ORAL Osmotic Pumps IMPLANTABLE Osmotic Pumps

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 14 Type of Implantable Osmotic Pumps

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 15 I) Rose-Nelson Osmotic Pump Rose and Nelson developed the first osmotic pump in 1955. The Osmotic pump was having three chamber. Water to be loaded prior to use was the drawbacks of rose nelson osmotic pump. Drug Chamber Elastic Diaphragm Salt Chamber Rigid Semi permeable membrane Delivery orifice Water Chamber

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 16 II) Higuchi Leeper Osmotic Pump It represents the first simplified version of Rose-Nelson pump. It contains a rigid housing and the semi permeable membrane, which is supported on a perforated frame. Rigid housing is divided in two chambers by a movable separator. It has a salt chamber containing saturated soln of Mgso4 with excess Mgso4 and Drug chamber. Rigid housing Movable seperator Membrane perforated frame Drug chamber salt chamber

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 17 III) Higuchi Theeuwes Osmotic Pump In early 1970s, Higuchi and Theeuwes developed a simpler form of Rose-Nelson Pump. Semi permeable wall itself acts as a rigid outer casing of the pump. The device is loaded with drug prior to use.

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 18 IV) Mini Osmotic Pump (ALZET) In vivo

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 19 Push Pull

I) Elementary Osmotic Pump : 

NaitikThakkar/ M.Pharm-II / Pharmaceutics 20 I) Elementary Osmotic Pump Rose Nelson pump was further simplified in the form of elementary osmotic pump by Theeuwes in 1975. It is fabricated as a tablet coated with SPM Normally EOP deliver 60 – 80 % of its content at constant rate. It has short lag time of 30 – 60 minute. LIMITATION: -

II)Osmotic Pump for Insoluble drugs : 

NaitikThakkar/ M.Pharm-II / Pharmaceutics 21 II)Osmotic Pump for Insoluble drugs For Insoluble Drugs Composition: particles of osmotic agents are coated with an elastic semipermeable membrane. These coated particles are then mixed with insoluble drug & tabletted & coated with rigid semipermeable membrane in usual way. Drug Release: When this system is placed in water it imbibes into the osmotic agent w/h swells & delivers insoluble drug out of orifice. Insoluble Drug Water Osmotic agent coated with elastic SPM

III) Controlled Porosity Osmotic Pump : 

NaitikThakkar/ M.Pharm-II / Pharmaceutics 22 III) Controlled Porosity Osmotic Pump It is not laser or micro driven orifice hence advantageneous over other osmotic system. The semi permeable coating membrane contains water-soluble pore forming agents. Example like NaCl, KCl, and Urea. Such formed pores becomes permeable for both water and solutes.

IV) LIQUID ORAL OSMOTIC SYSTEM (L-OROS) : 

NaitikThakkar/ M.Pharm-II / Pharmaceutics 23 IV) LIQUID ORAL OSMOTIC SYSTEM (L-OROS) Liquid OROS are designed to deliver drugs as liquid formulations and combine the benefits of extended release with high bioavailability. They are of following types: L OROS hard cap L OROS soft cap Composition: Liq. Drug formulation is present in a soft gelatin capsule w/h is surrounded with the barrier layer, the osmotic layer, and the release rate controlling membrane. A delivery orifice is formed through these layers

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 24 Drug Release: When the system comes in contact with aqueous environment, water permeates across the rate controlling membrane and activates the osmotic layer. The expansion of the osmotic layer results in the development of hydrostatic pressure inside the system, thereby forcing the liquid formulation to break through the hydrated gelatin capsule shell at the delivery orifice.

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 25 PPOP (Push Pull Osmotic Pump) They contain two or three compartment separated by elastic diaphragm. Upper compartment contain drug with or without osmogen (drug compartment nearly 60 – 80 %) and lower compartment (Push compartment) contain Osmogen at 20 – 40 %. Example ProcardiaXL for Nifedipine V) For Solid Osmotic System

VI) Monolithic Osmotic System : 

NaitikThakkar/ M.Pharm-II / Pharmaceutics 26 VI) Monolithic Osmotic System Dispersion of water soluble drug is made in a polymeric matrix and compressed as tablet. Tablet is then coated with semi permeable membrane . When MOS comes in contact with aqueous environment, the water penetrates in the core and forms a saturated solution of component which will generate osmotic pressure which results in the rupturing of membrane of polymeric matrix surrounding the agent. Thus liberating drug to move outside the environment. MOS is simple to prepare but the system fails if more then 20 – 30% volume of active agent is incorporated in device because above this level it leads to leaching of substance

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 27 COATING THICKNESS WEIGHT VARIATION DISSOLUTION FRIABILITY PORE DIAMETER IN VIVOEVALUATION THICKNESS HARDNESS Evaluation

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 28 IN VIVO EVALUATION In vivo evaluation carried out on dog, monkey (1983) studied of indomethacin from OROS pump in mongrel dogs. forty OROS systems of indomethacin were weighed and divided in to four groups of 20 and used for evaluation. IN VITRO EVALUATION oral osmotic system has been evaluated by the conventional USP paddle type apparatus. US patents describes use of commercial venkel standard dissolution apparatus and commercial applied analytical standard dissolution apparatus. The dissolution medium is generally distilled water, as well as gastric pH (For first 2-4 hrs)

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 29 In Vitro Drug Release In vitro drug release of the formulations was performed using United States Pharmacopeia’s (USP) type I apparatus (2100C, Distek Inc, North Brunswick, NJ) attached with auto-sampler, at 75 rpm. The dissolution medium consisted of 900 mL of degassed simulated gastric fluid (SGF, without enzymes) at 37°C ± 0.5°C. The drug release at different time intervals was analyzed by high-performance liquid chromatography (HPLC). The release studies were conducted in triplicate and parameters such as percentage cumulative drug release and drug release rate were calculated.

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 30 Applications of ODDS: Theeuwes (1985) developed elementary osmotic pump(EOP) for metoprolol and oxprenolol for once daily administration. For the desired solubility succinate salt of oxprenolol and fumarate salt of metoprolol were used along with sodium bicarbonate as osmotic agent. The systems were found to be stable after storage period of 2, 1, and 1 years at 23°, 37° and 51°C, respectively. In vitro release study was conducted using differential method apparatus, which indicated drug delivery (60%) at zero-order rates.

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 31 Vyas (1995) designed elementary osmotic pump, push-pull osmotic pump and diffusion pump of ciprofloxacin HCI using empty gelatin capsule shell. Elementary osmotic pump and push-pull osmotic pumps were coated with solution of cellulose acetate and diffusion pump was coated with emulsion of cellulose acetate solution and dextran solution (99:1). In case of push-pull osmotic pump, a swellable polymer was added in 1/3 part of capsule and separated drug and polymer layers with a septum. The extent of drug release was found in the decreasing order of push-pull osmotic pump (80%), elementary osmotic pump (60%) and diffusion pump (45%).

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 32 Conclusion Osmotic system technology has been extended to allow rate-controlled, constant drug delivery. These systems made 4- and 3-times-a-day regimens obsolete. Instead they made once-a-day dosing practical for many agents. For these and other reasons, the future of osmotic technology in drug delivery is bright!

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 33 Elementary osmotic pump Push-pull osmotic systems Market products

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 34 Implantable osmotic systems

References : 

NaitikThakkar/ M.Pharm-II / Pharmaceutics 35 References Roop K Khar, S.P Vyas, Controlled drug delivery concept & advances, 1st edition, page no-477-01. Lachman L., Liberman H. A., Kanig J. L., The theory and practice of industrial pharmacy. 2nd Edition 1991, Varghese publishing house, P=455. Aulton M. E., pharmaceutics the science of dosage form design. 2nd Edition 2002, Churchill livingstone, P=38, 39, 74, 304, 417. N.K.Jain advances in controlled and novel drug delivery, CBS Publisher & distributor. FIRST EDITION.Review Article ISSN: 0974-6943 www.jpronline.info Review Article JPRHC January 2010 Volume 2 Issue 1 www.pharmainfo.in http://scholarsresearchlibrary.com/archive.html

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NaitikThakkar/ M.Pharm-II / Pharmaceutics 36

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