A COMPLETE RECAPITULATION OF A DRUG DELIVERY BASED ON OSMOTIC PRESSURE: AN OSMOTIC DRUG DELIVERY SYSTEM

A COMPLETE RECAPITULATION OF A DRUG DELIVERY BASED ON OSMOTIC PRESSURE: AN OSMOTIC DRUG DELIVERY SYSTEM

Alla Monisha *, M. Mohan Varma, D. Basava Raju

Department of Formulation Research & Development, Aurigene Pharmaceutical Services (Subsidiary of Dr. Reddy’s Laboratories), CPS, Miyapur, Hyderabad, Telangana, India.

ABSTRACT: Conventional dosage forms are the systems that don't have complete control on their drug release, and also there is no control over the effective concentration at the target site. So in order to overcome this problem the osmotic drug delivery system was developed for the controlled delivery of drugs. This osmotic drug delivery system includes dosage forms for oral administration and implantable systems where they provide controlled delivery of drugs. These systems contain osmotic agents and a semipermeable membrane where they play an important role in the development of these delivery systems. This review mainly concentrates on the main Advantages, the principle of osmosis and how the drugs are delivered by using osmotic pressure, historical background, Types of osmotic drug delivery - Implantable and oral osmotic system, their pictorial representations and mechanisms, factors influencing the drug release, scientific developments and Marketed products of osmotic drug delivery systems.

Keywords: Implantable devices, Oral osmotic device, Osmogents, Osmotic pressure, Drug delivery orifice, Semipermeable membrane, Pumping devices, Push & Pull layers

INTRODUCTION: Oral drug delivery is one of the oldest and most widely used routes for the administration of drugs for achieving local and systemic effects. In this, the conventional dosage forms are able to give an immediate release of drugs but they are unable to control the drug release and they cannot maintain effective concentration at the target site for a longer period of time. In turn, the bioavailability of drugs purely depends on the physicochemical properties of a drug, excipients, and many physiological factors ^1,2.

Due to all these limitations of the conventional dosage form, researchers have concentrated on developing novel drug delivery systems (NDDS), which is a key area of (FR&D) pharmaceutical research and development. This NDDS controlled release drug delivery system has gained more importance because of its many advantages than conventional dosage forms.

Controlled release drugs are easy to administer, have better patient compliance and decrease dosing frequency where the main goal of controlled release drug delivery is to improve the efficacy of drugs by prolonging the drug release for an extended period of time ³. In this novel drug delivery system, the drug release can be regulated by preparing them in different ways such as matrix system, reservoir system and osmotic systems. Where the osmotic drug delivery Systems are more well-founded controlled release drug delivery systems, which can be administered orally ⁴. Here in this osmotic drug delivery system, osmotic pressure is used as a driving force to release the drug in a controlled manner ⁵. Drug release from this system is independent of pH and other physiological parameters ⁶. There are many advantages of osmotically controlled drug delivery systems given in the following Table 1. Osmotic drug delivery systems have many benefits practically when compared to conventional dosage forms. Whereas they also have some disadvantages. Some distinct advantages and disadvantages of Osmotic drug delivery systems are as follows.

TABLE 1: ADVANTAGES AND DISADVANTAGES OF OSMOTICALLY DRUG DELIVERY SYSTEMS ^{7, 14}

Limitations: Moreover, in addition to these, there are certain limitations associated with these osmotic drug delivery systems they are.

• They may cause ulcers due to the release of a saturated solution.
• Extraordinary systems are necessary for making orifices to the device, resulting in an increase in making costs.
• Experienced personnels are required for the production of these osmotic drug delivery devices.
• Residence time of the osmotic drug delivery system in the body may vary with gastric motility and after eating food.

Historical Background ^{14, 22}: In the year 1955, two scientists Rose and Nelson used osmosis principle for the first time in drug delivery systems and they have developed an implantable pump that consists of three chambers.  In 1970’s Higuchi and Leeper developed and proposed a series of variations in the Rose and Nelson pump. Then in 1974, the scientist Theeuwes developed the first osmotic drug delivery concept; also he simplified the Rose-Nelson pump which was developed by Alza Corporation of the USA and also he developed an elementary osmotic pump and holds several patents and released many osmotic drug delivery system products in the market.

Later the Rose-Nelson pump was further simplified and developed by Higuchi and Theeuwes. And also, they have designed a tablet that contains a core surrounded by a semipermeable membrane that contains an orifice. In the 1980's the first two osmotic drug delivery products were released into the market; they are indomethacin, Osmosin and phenylpropanolamine. Osmosin, which is an elementary osmotic pump, was withdrawn from the market due to its large number of side effects. Zentner et al. in 1985-1991, Zentner and Rork in 1990, Appel and Zentner and Mcclelland et al. In 1991, they developed a controlled-porosity osmotic pump tablet as an oral drug delivery system. Later oral osmotic drug delivery system was further developed with two new designs one delivered 0.02 ml/day for 100 days and the other delivered 0.5 ml/ day for 4 days, both are used in pharmacological research, they are push-pull osmotic pumps (PPOP) it was developed for the application of poorly water soluble drugs to the targeted site and controlled-porosity osmotic pumps (CPOP) was developed to decrease the risk of drug induced irritation.

Osmosis & ITS Principle ^{23, 25}: Osmosis is a process by which molecules of a solvent tend to pass through a semipermeable membrane from a low concentrated solution into a highly concentrated one. This osmosis process is able to control drug delivery. This type of osmotic drug delivery device contains osmogent, due to which osmotic pressure is created. (The osmotic pressure of a solution is the external pressure applied to the solution to prevent it from being diluted by the entry of solvent via the osmosis process. So that when this device comes in contact with fluids, osmotic pressure is created, due to high osmotic pressure inside the device, the drug pushes outside.

Moreover the release rate of the drugs from osmotic drug delivery devices depends on molecular weight, solubility and activity coefficient of the solute (osmogent). According to the Pfeffer experiment, it was reported that the membrane is permeable to water but the membrane-impermeable to sugars is used to separate a sugar solution from the pure water. He showed that the osmotic pressure π of the sugar solution is directly proportional to the concentration of the solution and absolute temperature. Later within a few years, Van't Hoff shows the comparison between these results and ideal gas law with the following equation.

π = Ф c r t Where, π = Osmotic pressure. Ф = Osmotic coefficient of the solution. C = Molar concentration of sugar in the solution. r = Gas constant t = Absolute temperature

Osmotic pressure for the concentrated solution of soluble solutes commonly used for controlled release formulation; their osmotic pressure can produce high water flow across the semipermeable membrane. The osmotic water flows through a membrane is given by equation.

Dv/dt = A Q Δ π/ Where, dvdt = Water flows across the membrane. A = Area. L = Thickness. ?π = Osmotic pressure. Q = Permeability.

Therefore this equation strictly says that the membrane is permeable to water, but it is impermeable to osmotic agents.

Rate of Drug Delivery from the Device Is Directly Proportional To The:

• Amount of osmotic agents in the device.
• Drug solubility modifier ratio.
• Level of pore former.
• Thickness and composition of semi permeable membranes.
• Size of hole/ aperture.
• Surface area of the device.

The Drug Release Is Inversely Proportional To: Concentration of polymer coating. Membrane thickness or weight gain.

Principle Components of Osmotic Drug Delivery System: (1) Drug, (2) Semipermeable membrane, (3) Osmotic agent (or) Osmogen, (4) Pore-forming agent, (5) Wicking agent, (6) Coating solvents, (7) Flux Regulators, (8) Plasticisers, (9) Solubilizing agents, (10) Surfactants.

Drug ^{13, 27}: All drugs are not suitable to develop as an osmotic drug delivery device. Examples of some drugs that are suitable to develop into osmotic drug delivery are given in Table 2. Basic characteristics that are required for a drug to develop into osmotic drug delivery system are as follows. Should have a short biological half-life 2-6 h. It should be a highly potent drug. Solubility should not be either high or low. Drugs should be suitable for prolonged treatment. The drug should itself have an osmogenicproperty and should have a good aqueous solubility.  If the drug should not possess osmotic properties, then osmotic salts and other sugars are incorporated in the formulation.

Semi-Permeable Membrane ^{28, 52}: The membrane which is present in the osmotic drug delivery system is semipermeable in nature. So, the polymers that are used in this system should be permeable to water and impermeable to solutes that are present. The semipermeable membrane plays an important role in the osmotic drug delivery system, so we have to be very careful in the selection of material for the semipermeable membrane.

The semipermeable membrane must meet some criteria, they are. It should be permeable to water. It should have sufficient wetting strength and wet modulus in order to retain its shape during the lifetime of the device. The Leakiness and reflection coefficient of an osmotic agent should approach the limiting value. Membrane should be biocompatible.

Osmotic Agent (or) Osmogen ^{25, 33, 35}: Osmotic agents (or) Osmogen are the essential ingredients in the osmotic drug delivery formulation. These osmogents are the materials that are used to create osmotic pressure inside the system. Osmotic agents or osmogens protect the concentration gradient across the membrane. They also create a driving force for the uptake of water and helps in and also helps in maintaining drug consistency in the hydrated form. Upon the perception of biological fluid into the osmotic device through a semipermeable membrane, then the osmogents are dissolved in the penetrated fluids, so that the osmotic pressure is created, inside the pump where due to high osmotic pressure the drug or medicament which is present inside the device and pushes the medicament outside through delivery orifice, in a controlled manner.

The release rate from the device is purely based on the osmotic pressure that is created inside the device. So in order to maintain the drug release rate osmotic agents are added to the formulation. When the drug solubility is low, then it shows a zero-order release. The most commonly used osmogents are given in Table 2. Osmotic agents used in the formulation either alone or in combination (mixture) of osmogents. Different types of osmogents present are (1) Water-soluble salts of inorganic acids, (2) -soluble salts of organic acids, (3) Carbohydrates, (4) Water-soluble amino acids and organic polymeric Osmogens.

Pore Forming Agents (Or) Channellingagents ^{36, 41}: Pore-forming agents are the materials that are used for the formation of microporous membranes. The microporous wall may be formed in-vivo by the former pore agent by its percolation of fluids during the operation of the system. These pore-forming agents are particularly used in the development of poorly water-soluble drugs and used in the preparation of multi particulate and controlled porosity osmotic pumps. The pore-forming agents may be organic or inorganic and also either in solid or in liquid form. Different examples of pore-forming agents are given in Table 2. These pore-forming agents are also called channelling agents. When the dissolution fluid comes in contact with the semipermeable membrane, then due to the presence of pore formers or channelling agent forms a pore on the semipermeable membrane, through which the drug releases in a controlled manner.

Wicking Agents ^{32, 42}: Wicking agent is defined as the material that has the ability to pull up water into a porous network of the drug delivery device. Also, these wicking agents have the ability to increase the contact surface area of the drug with the incoming aqueous fluid. These agents are either swellable or Non-swellable in nature; different examples of wicking agents are mentioned in Table 2. And these are characterized by having an ability to undergo physisorption with water. The main function of this wicking agent is to carry water to the surface inside the tablet core by creating a channel. The use of these wicking agents in the drug delivery device is to enhance the drug release from the orifice of the device.

Coating Solvents ^{44, 46}: Solvents that are suitable for making a polymeric solution is used in the preparation of coating material. The main function of these solvents is to disperse the polymer and other additives that are used for coating an osmotic device. Inert inorganic and organic solvents are used in the preparation of the outer layer or walls of osmotic drug delivery devices. Examples of different types of solvents are given in Table 2.

Flux Regulators ^{47, 48}: In order to regulate the flow of fluids into the drug delivery device, flux regulators are incorporated in the layer of the drug device, i.e. these flux regulators are added to the wall forming agents. There are different types of flux regulators used are hydrophilic and hydrophobic substances. Examples of flux regulators are given in Table 2.

Plasticizers ^{47, 51}: Plasticizers have the capacity to change the visco-elastic nature of the polymer, so these plasticizers are used in the coating membrane of the osmotic drug delivery systems.

Due to the addition of these plasticizers, the permeability of film may change. Plasticizers have the capacity to turn a hard and brittle polymer into a softer, more pliable material and possibly make the upper layer or film more resistant to mechanical stress. Different types of plasticizers are given in Table 2.

Solubilizing Agents ⁵²: Solubilizing agents are used to increasing the solubility of drugs in the gastrointestinal tract. Primarily used in the osmotic systems that contain low soluble drugs. Examples of these solubilizing agents are given in Table 2.

Surfactants ⁵³: Surfactants are the agents that act by modifying the surface energy of resources to get better their blending into the compound and upload their reliability in the environment of use during the drug release period. Some examples of surfactants are given in Table 2.

TABLE 2: TABLE SHOWING DIFFERENT EXAMPLES OF THE PRINCIPLE COMPONENTS USED IN THE OSMOTIC DRUG DELIVERY SYSTEM

Types of Osmotic Drug Delivery System ^{10, 27}: There are two different types of osmotically controlled drug delivery system. They are as follows in Table 3.

TABLE 3: TYPES OF IMPLANTABLE OSMOTIC DRUG DELIVERY SYSTEM

FIG. 1: SHOWING THE SCHEMATIC REPRESENTATION OF THE BASIC MODEL OF OSMOTIC PRESSURE POWERED DRUG DELIVERY SYSTEMS

FIG. 2:  ROSE NELSON PUMP                                   

FIG. 3: HIGUCHI LEEPER OSMOTIC PUMP

 FIG. 4:  HIGUCHI THEEUWES OSMOTIC PUMP                              

FIG. 5:  ALZET OSMOTIC PUMP

FIG. 6:  DUROS OSMOTIC PUMP.

FIG. 7:  IMPLANTABLE MINI OSMOTIC PUMP

TYPES OF ORAL OSMOTIC DRUG DELIVERY SYSTEM

 FIG. 8:  ELEMENTARY OSMOTIC PUMP                   

FIG. 9:  PUSH-PULL OSMOTIC PUMP

FIG. 10, 11: SANDWICHED OSMOTIC PUMP, OSMOTIC PUMP WITH NON EXPANDING SECOND CHAMBER

FIG. 12, 13: ASYMMETRIC MEMBRANE OSMOTIC PUMP, LIQUID OSMOTIC SYSTEM (L-OROS)

FIG. 14, 15:  L-OROS SOFT GELATIN CAPSULE, TELESCOPIC CAPSULE FOR DELAYED RELEASE

FIG. 16: CONTROLLED-POROSITY OSMOTIC PUMPS

FIG. 17: OSMOTIC BURSTING OSMOTIC PUMPS

FIG. 18: MONOLITHIC OSMOTIC PUMP TABLET         

FIG. 19: OROS-CT COLON TARGETING

FIG. 20, 21: SELF EMULSIFIED OSMOTIC SYSTEM MULTI, PARTICULATE DELAYED RELEASE SYSTEM

FIG. 22: FLOATING ELEMENTARY OSMOTIC PUMP TABLET

Creation of Delivery Orifice ^{103, 104}: Delivery orifice for the osmotic drug delivery devices may be created by using different mechanical drilling equipment, Some of the methods to produce a delivery orifice in the osmotic tablet coating are (1) Laser Drill, (2) Indentation that is Not Covered During the Coating Process, (3) Use of Leachable Substances in the Semi-Permeable Coating, (4). Systems with Passageway Produced In-Situ are some of the methods to make a delivery orifice. Out of which laser drilling technique is a mostly used technique for the creation of delivery orifice to the osmotic tablet, the main mechanism involved in this technique is the laser beam is projected on the surface of the tablet then it absorbs the energy of the beam and gets heated that causing a hole to the tablet wall which is a delivery orifice. And the size of the delivery orifice can be controlled by varying different parameters like by controlling the laser power, firing duration (pulse time), the thickness of the wall, and the dimensions of the beam at the wall. Whereas in some osmotic drug delivery systems we can see the in situ formation of delivery orifice that is achieved by incorporating different types of pore-forming agents (these pore-forming agents are water-soluble) in the wall during the coating process. The size of the delivery orifice must be perfect for controlling the drug release from the osmotic device. And the size of the delivery orifice should not also be too large or too small because if it is too large, the drug solute diffusion from the orifice may take place. Or if the size of the delivery orifice is too small, then it will affect the zero-order delivery due to the development of hydrostatic pressure within the core.  So the delivery orifice size must be appropriate to achieve the desired drug release from the osmotic device. And the size of the delivery orifice should not also be too large or too small because if it is too large, the drug solute diffusion from the orifice may take place. Or if the size of the delivery orifice is too small, then it will affect the zero-order delivery due to the development of hydrostatic pressure within the core. So the delivery orifice size must be appropriate to achieve the desired drug release from the osmotic device.

Factors Affecting Osmotic Drug Delivery System ^{98, 104}:

Evaluation Parameters ^{105, 106}: Evaluation of osmotic drug delivery devices can be done by studying the following parameters, Hardness, Weight Variation, Visual Inspection Of Tablets, Coating Thickness & Coat Weight, Coating Uniformity, Friability, Pore (Or) Orifice Diameter, In-vitro Dissolution Studies, By Using Methods Like Vertically Reciprocating Shaker, Conventional Usp Dissolution Apparatus I And Ii, Flow-Through Apparatus, In-vivo Evaluation, In-vitro - In-vivo Correlation, Kinetics Of Drug Release.

SCIENTIFIC STUDIES ^{48, 56, 72, 95, 107, 112}

DIFFERENT MARKETED PRODUCTS

CONCLUSION: In osmotic drug delivery systems, osmotic pressure plays an important role for the delivery of drugs from the device, due to the development of high osmotic pressure inside the osmotic system, the drug releases from the device. So it can be said that the drug release from the osmotic device is purely based on the osmotic pressure that is developed inside the system. In addition to these, there are many pulsatile-based delivery systems based on expandable orifice, lipid osmotic pumps, telescopic capsules containing mini osmotic pumps for delayed-release, osmotic bursting osmotic pump and many more osmotic systems are developed for controlled release. So It can be concluded that both implantable and oral osmotic drug delivery systems can be used in the field of controlled drug delivery systems. The development of these Osmotic drug delivery systems has gained a lot of importance with the appearance of new technologies and products.

ACKNOWLEDMENT: Nil

CONFLICTS OF INTEREST: Nil

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     How to cite this article:

     Monisha A, Varma MM, Basava DR: A complete recapitulation of a drug delivery based on osmotic pressure: an osmotic drug delivery system. Int J Pharm Sci & Res 2021; 12(10): 5264-80. doi: 10.13040/IJPSR.0975-8232.12(10).5264-80.

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