US4008719A — Osmotic system having laminar arrangement for pro…

Claim 1

Independent Claim 231 words

An osmotic system for dispensing an active agent to an environment of use, said system comprising: a. a shaped wall comprising a pair of laminae comprising an exterior lamina consisting of a multiplicity of materials blended to form a lamina that is permeable to the passage of an external fluid and maintains its physical and chemical integrity in the environment of use, and an interior lamina consisting of a multiplicity of materials blended to form a lamina that is permeable to the passage of an external fluid, substantially impermeable to the passage of agent and maintains its physical and chemical integrity in the presence of agent, said wall surrounding, with the interior lamina facing; b. a compartment containing an active agent that is soluble in the fluid and exhibits an osmotic pressure gradient across the wall against the fluid; c. a compartment in the wall communicating with the compartment and the exterior of the device for dispensing agent from the device; and d. wherein in operation when the device is in the environment of use, fluid from the environment is continually inbibed through the wall into the compartment in a tendency towards osmotic equilibrium at a rate determined by the permeability of the wall and the osmotic pressure gradient across the wall, thereby continuously dissolving agent which is dispensed at a controlled and continuous rate over a prolonged period of time.

Claim 2

Dependent Claim 231 words

An osmotic system for dispensing an active agent to an environment of use, said system comprising: a. a shaped wall comprising a pair of laminae comprising an exterior lamina consisting of a multiplicity of materials blended to form a lamina that is permeable to the passage of an external fluid and maintains its physical and chemical integrity in the environment of use, and an interior lamina consisting of a multiplicity of materials blended to form a lamina that is permeable to the passage of an external fluid, substantially impermeable to the passage of agent and maintains its physical and chemical integrity in the presence of agent, said wall surrounding, with the interior lamina facing; b. a compartment containing an active agent that is soluble in the fluid and exhibits an osmotic pressure gradient across the wall against the fluid; c. a compartment in the wall communicating with the compartment and the exterior of the device for dispensing agent from the device; and d. wherein in operation when the device is in the environment of use, fluid from the environment is continually inbibed through the wall into the compartment in a tendency towards osmotic equilibrium at a rate determined by the permeability of the wall and the osmotic pressure gradient across the wall, thereby continuously dissolving agent which is dispensed at a controlled and continuous rate over a prolonged period of time.

Claim 3

Dependent Claim 25 words

The osmotic system for dispensing an agent according to claim 1 wherein the exterior lamina is substantially non-erodible and inert in the environment of use.

Claim 4

Dependent Claim 28 words

The osmotic system for dispensing an agent according to claim 1 wherein the interior lamina is substantially non-erodible and inert in the presence of agent and solutions thereof.

Claim 5

Dependent Claim 22 words

The osmotic system for dispensing an agent according to claim 1 wherein the laminae comprise at least one semipermeable lamina forming material.

Claim 6

Dependent Claim 36 words

The osmotic system for dispensing an agent according to claim 1 wherein the laminae comprise a cellulose ester having a degree of substitution on its anhydroglucose groups of greater than 0 and up to 3 inclusive.

Claim 7

Dependent Claim 44 words

The osmotic system for dispensing an agent according to claim 1 wherein the laminae contain a member selected from the group consisting of cellulose acylates, cellulose diacylates, cellulose triacylates, cellulose acetate, cellulose diacetate, cellulose triacetate, cellulose propionate, cellulose acetate propionate and cellulose acetate butyrate.

Claim 8

Dependent Claim 25 words

The osmotic system for dispensing an agent according to claim 1 wherein the laminae contain at least one material that imparts stability to the laminae.

Claim 9

Dependent Claim 31 words

The osmotic system for dispensing an agent according to claim 1 wherein the system is sized, shaped and adapted as a dosage form for dispensing an agent in the gastrointestinal tract.

Claim 10

Dependent Claim 21 words

The osmotic system for dispensing an agent according to claim 1 wherein the passageway is formed in the environment of use.

Claim 11

Dependent Claim 28 words

The osmtoic system for dispensing an agent according to claim 1 wherein the agent is a member selected from the group consisting of locally and systemically acting drugs.

Claim 12

Dependent Claim 39 words

The osmotic system for dispensing an agent according to claim 1 wherein the agent is a member selected from the group consisting of acetazolamide, methazolamide, potassium chloride, niacin, aspirin, meprobamate, salicylamide, theophylline monoethanolamine, aminophylline, procainamide hydrochloride, colchicine and atropine.

Claim 13

Dependent Claim 17 words

The osmotic system for dispensing an agent according to claim 1 wherein the laminae contain a plasticizer.

Claim 14

Dependent Claim 27 words

The osmotic system for dispensing an agent according to claim 1 wherein the laminae containing a plasticizer selected from the group consisting of cyclic and acyclic plasticizers.

Claim 15

Dependent Claim 23 words

The osmotic system for dispensing an agent according to claim 1 wherein the laminae contain an amphipatic dispersant comprising hydrophilic and hydrophobic groups.

Claim 16

Dependent Claim 25 words

The osmotic system according to claim 1 wherein the laminae contain a dispersant selected from the group consisting of anionic, cationic, nonionic and amphoteric dispersants.

Claim 17

Dependent Claim 32 words

The osmotic system for dispersing an agent according to claim 1 wherein the laminae contain a flux regulator that decreases or increases the permeability of the laminae to the passage of fluid.

Claim 18

Dependent Claim 18 words

The osmotic system for dispensing an agent according to claim 1 wherein the laminae contain a cellulose ether.

Claim 19

Dependent Claim 36 words

The osmotic system for dispensing an agent according to claim 1 wherein the compartment contains an osmotically effective compound that exhibits an osmotic pressure gradient across the wall from greater than 0 up to 500 atmospheres.

Claim 20

Dependent Claim 24 words

The osmotic system for dispensing an agent according to claim 1 wherein the system is sized, shaped and adapted for placement in a vagina.

Claim 21

Dependent Claim 223 words

An osmotic system for the continuous dispensing of an active agent to an environment of use comprising: a. a shaped wall comprising an interior lamina consisting of at least two materials that form a lamina permeable to the passage of an external fluid, substantially impermeable to the passage of agent and essentially mantains its physical and chemical integrity in the presence of agent, said lamina in laminar arrangement with an exterior lamina formed of a material permeable to the passage of fluid and essentially maintains is physical and chemical integrity in the environment of use, said wall surrounding, with the interior lamina facing; b. a compartment containing the active agent that is soluble in the external fluid and exhibits an osmotic pressure gradient across the wall against the fluid; c. a passageway in the wall communicating with the compartment and the exterior of the system for dispensing agent from the system; and, d. wherein in operation when the system is placed in the environment of use, fluid from the environment is imbibed through the wall into the compartment in a tendency towards osmotic equilibrium at a rate determined by the permeability of the wall and the osmotic pressure gradient across the wall, thereby dissolving agent which is dispersed through the passageway at a controlled and continuous rate over a prolonged period of time.

Claim 22

Dependent Claim 223 words

An osmotic system for the continuous dispensing of an active agent to an environment of use comprising: a. a shaped wall comprising an interior lamina consisting of at least two materials that form a lamina permeable to the passage of an external fluid, substantially impermeable to the passage of agent and essentially mantains its physical and chemical integrity in the presence of agent, said lamina in laminar arrangement with an exterior lamina formed of a material permeable to the passage of fluid and essentially maintains is physical and chemical integrity in the environment of use, said wall surrounding, with the interior lamina facing; b. a compartment containing the active agent that is soluble in the external fluid and exhibits an osmotic pressure gradient across the wall against the fluid; c. a passageway in the wall communicating with the compartment and the exterior of the system for dispensing agent from the system; and, d. wherein in operation when the system is placed in the environment of use, fluid from the environment is imbibed through the wall into the compartment in a tendency towards osmotic equilibrium at a rate determined by the permeability of the wall and the osmotic pressure gradient across the wall, thereby dissolving agent which is dispersed through the passageway at a controlled and continuous rate over a prolonged period of time.

Claim 23

Dependent Claim 31 words

The osmotic system for dispensing an agent according to claim 20 wherein the interior lamina is formed of a semipermeable material and a stabilizing material that imparts integrity to the lamina.

Claim 24

Dependent Claim 31 words

The osmotic system for dispensing an agent according to claim 20 wherein the interior lamina is formed of a semipermeable material, a stabilizing material and a dispersant that blends the materials.

Claim 25

Dependent Claim 29 words

The osmotic system for dispensing an agent according to claim 20 wherein the interior lamina is formed of a semipermeable material, a stabilizing material, a dispersant, and a plasticizer.

Claim 26

Dependent Claim 32 words

The osmotic system for dispensing an agent according to claim 20 wherein the interior lamina is formed of a semipermeable material, a stabilizing material, a dispersant, a plasticizer, and a flux regulator.

Claim 27

Dependent Claim 37 words

The osmotic system for dispensing an agent according to claim 20 wherein the interior lamina contains a cellulose ester having a degree of substitution on its anhydroglucose groups of greater than 0 and up to 3 inclusive.

Claim 28

Dependent Claim 45 words

The osmotic system for dispensing an agent according to claim 20 wherein the interior lamina contains a member selected from the group consisting of cellulose acylates, cellulose diacylates, cellulose triacylates, cellulose acetate, cellulose diacetate, cellulose triacetate, cellulose propionate, cellulose acetate propionate, and cellulose acetate butyrate.

Claim 29

Dependent Claim 49 words

The osmotic system for dispensing an agent according to claim 20 wherein the interior lamina contains a stabilizing material selected from the group consisting of cellulose esters having on its anhydroglucose groups a degree of substitution greater than 0 and up to 3 inclusive, cellulose ethers and mixtures thereof.

Claim 30

Dependent Claim 61 words

The osmotic system for dispensing an agent according to claim 20 wherein the interior lamina contains a semipermeable material and a stabilizing material possessing different chemical and physical properties than the semipermeable material and selected from the group consisting of cellulose acylates, cellulose diacylates, cellulose triacylates, cellulose acetate, cellulose diacetate, cellulose triacetate, hydroxymethyl cellulose, hydroxypropyl methylcellulose, hydroxybutyl methylcellulose, and mixtures thereof.

Claim 31

Dependent Claim 31 words

The osmotic system for dispensing an agent according to claim 20 wherein the interior lamina contains a plasticizer selected from the group consisting of cyclic and acyclic plasticizers and mixtures thereof.

Claim 32

Dependent Claim 39 words

The osmotic system for dispensing an agent according to claim 20 wherein the interior lamina contains a plasticizer selected from the group consisting of phthalates, phosphates, citrates, adipates, tartrates, sebacates, succinates, glycolates, glycerolates, benzoates, myristates, sulfonamides and halogenated phenyls.

Claim 33

Dependent Claim 33 words

The osmotic system for dispensing an agent according to claim 20 wherein the interior lamina contains a dispersant selected from the group consisting of anionic, cationic, nonionic and amphoteric dispersants, and mixtures thereof.

Claim 34

Dependent Claim 50 words

The osmotic system for dispensing an agent according to claim 20 wherein the interior lamina contains a dispersant selected from the group consisting of polyoxyalkylene glycol, esters of polyoxyalkylene glycols, esters of polyhydric alcohols, sulfated esters, sulfated amides, quaternary ammonium salts, alkanolamine fatty acids, tertiary alkylamonium salts, and mixtures thereof.

Claim 35

Dependent Claim 27 words

The osmotic system for dispensing an agent according to claim 20 wherein the system is sized, shaped and adapted for dispensing an agent in the gastrointestinal tract.

Claim 36

Dependent Claim 28 words

The osmotic system for dispensing an agent according to claim 20 wherein the agent is a member selected from the group consisting of locally and systemically acting drugs.

Claim 37

Dependent Claim 22 words

The osmotic system for dispensing an agent according to claim 20 wherein the soluble agent is mixed with an osmotically effective compound.

Claim 38

Dependent Claim 21 words

The osmotic system for dispensing an agent according to claim 20 wherein the passageway is formed in the environment of use.

Claim 39

Dependent Claim 39 words

The osmotic system for dispensing an agent according to claim 20 wherein the agent in the compartment is mixed with a member selected from the group consisting of a binder, a pharmaceutically acceptable dye, a lubricant, and mixtures thereof.

Claim 40

Dependent Claim 34 words

The osmotic system for dispensing an agent according to claim 20 wherein the agent is a member selected from the group consisting of tolbulamide, tolazamide, chloropropamide, mannitol hexanitrate, tranylcypromine, progestational steroids, and estrogenic steroids.

Claim 41

Dependent Claim 37 words

The osmotic system for dispensing an agent according to claim 20 wherein the interior lamina contains a flux regulator selected from the group consiting of aliphatic diols, polyalkylene glycols, poly(α,ω)-alkylenediols, esters of alkylene glycols and mixtures thereof.

Claim 42

Dependent Claim 29 words

The osmotic system for dispensing an agent according to claim 20 wherein the exterior lamina is a member selected from the group consisting of cellulose ethers, polyamides and polyurethanes.

Claim 43

Dependent Claim 217 words

An osmotic system for the continuous dispensing of an active agent to an environment of use comprising: a. a shaped wall comprising an interior lamina formed of a semipermeable material that is permeable to the passage of an external fluid, substantially impermeable to the passage of agent and essentially maintains its physical and chemical integrity in the presence of agent, said lamina laminated to an exterior lamina formed of at least two materials with the lamina permeable to the passage of fluid and essentially maintains its physical and chemical integrity in the environment of use, said wall surrounding, with the interior lamina facing; b. a compartment containing an active agent that is soluble in the external fluid and exhibits an osmtoic pressure gradient across the wall against the fluid; c. a passageway in the wall communicating with the compartment and the exterior of the system for dispensing agent from the system; and, d. wherein in operation when the system is placed in the environment of use, fluid from the environment is imbibed through the wall into the compartment in a tendency towards osmotic equilibrium at a rate determined by the osmotic pressure gradient across the wall, thereby dissolving agent which is dispensed through the passageway at a controlled and continuous rate over a prolonged period of time.

Claim 44

Dependent Claim 217 words

An osmotic system for the continuous dispensing of an active agent to an environment of use comprising: a. a shaped wall comprising an interior lamina formed of a semipermeable material that is permeable to the passage of an external fluid, substantially impermeable to the passage of agent and essentially maintains its physical and chemical integrity in the presence of agent, said lamina laminated to an exterior lamina formed of at least two materials with the lamina permeable to the passage of fluid and essentially maintains its physical and chemical integrity in the environment of use, said wall surrounding, with the interior lamina facing; b. a compartment containing an active agent that is soluble in the external fluid and exhibits an osmtoic pressure gradient across the wall against the fluid; c. a passageway in the wall communicating with the compartment and the exterior of the system for dispensing agent from the system; and, d. wherein in operation when the system is placed in the environment of use, fluid from the environment is imbibed through the wall into the compartment in a tendency towards osmotic equilibrium at a rate determined by the osmotic pressure gradient across the wall, thereby dissolving agent which is dispensed through the passageway at a controlled and continuous rate over a prolonged period of time.

Claim 45

Dependent Claim 22 words

The osmotic system for dispensing an agent according to claim 41 wherein the semipermeable material forming the interior lamina is a polymer.

Claim 46

Dependent Claim 34 words

The osmotic system for dispensing an agent according to claim 41 wherein the exterior lamina comprises a semipermeable polymeric lamina forming material blended with a hydrophobic stabilizing material and a hydrophilic flux regulating material.

Claim 47

Dependent Claim 21 words

The osmotic system for dispensing an agent according to claim 41 wherein the passageway is formed in the environment of use.

Claim 48

Dependent Claim 26 words

The osmotic system for dispensing an agent according to claim 41 wherein the exterior lamina comprises a semipermeable polymeric lamina forming material blended with a plasticizer.

Claim 49

Dependent Claim 40 words

The osmotic system for dispensing an agent according to claim 41 wherein the exterior lamina comprises a semipermeable polymer, a stabilizing material, a dispersant, a flux regulating material and a plasticizer that lowers the glass transition temperature of the polymer.

Claim 50

Dependent Claim 53 words

The osmotic system for dispensing an agent according to claim 41 wherein the agent is a drug and the system is sized, shaped and adapted for dispensing the drug to a receptor selected from the group consisting of eye, ear, nose, gastrointestinal ract, vagina, uterus, anus, skin, and systemic circulation drug receptor sites.

Claim 51

Dependent Claim 41 words

The osmotic system for dispensing an agent according to claim 41 wherein the agent is a member selected from the group consisting of idoxuridine, phenylephrine, pilocarpine, pilocarpine salts, eserine, carbachol, phospholine iodine, demecarium bromide, cyclopentolate, homatropine, scopolamine, epinephrine and mixtures thereof.

Claim 52

Dependent Claim 215 words

An osmotic system for the continuous dispensing of an active agent to an environment of use comprising: a. a shaped laminated wall comprising at least two laminae comprising a multiplicity of materials, said laminae forming a laminated wall that is permeable to the passage of an external fluid and substantially impermeable to the passage of agent with the wall surrounding and forming; b. a compartment containing an active agent; c. a passageway in the wall communicating with the compartment and the exterior of the system for dispensing agent from the system; and, d. wherein the operation, when the system is placed in the environment of use, fluid from the environment is continuously imbibed through the laminated wall, having a total thickness h t , into the compartment in a tendency towards osmotic equilibrium at a rate proportional to the fluid transmission rate (kπ) t of the laminated wall which rate is governed by the following equation: ##EQU5## wherein h 1 , h 2 and h n are the thickness of the individual lamina, and (kπ) 1 , (kπ) 2 and (kπ) n are the fluid transmission rates for the respective laminae, said imbibed fluid continuously dissolving agent which is dispensed from the system at a controlled and continuous rate over a prolonged period of time.

Claim 53

Dependent Claim 215 words

An osmotic system for the continuous dispensing of an active agent to an environment of use comprising: a. a shaped laminated wall comprising at least two laminae comprising a multiplicity of materials, said laminae forming a laminated wall that is permeable to the passage of an external fluid and substantially impermeable to the passage of agent with the wall surrounding and forming; b. a compartment containing an active agent; c. a passageway in the wall communicating with the compartment and the exterior of the system for dispensing agent from the system; and, d. wherein the operation, when the system is placed in the environment of use, fluid from the environment is continuously imbibed through the laminated wall, having a total thickness h t , into the compartment in a tendency towards osmotic equilibrium at a rate proportional to the fluid transmission rate (kπ) t of the laminated wall which rate is governed by the following equation: ##EQU5## wherein h 1 , h 2 and h n are the thickness of the individual lamina, and (kπ) 1 , (kπ) 2 and (kπ) n are the fluid transmission rates for the respective laminae, said imbibed fluid continuously dissolving agent which is dispensed from the system at a controlled and continuous rate over a prolonged period of time.

Claim 54

Dependent Claim 36 words

An osmotic system for continuously dispensing an agent according to claim 49 wherein the laminated wall comprises a lamina that is substantially impermeable to agent in the compartment and to compounds in the environment of use.

Claim 55

Dependent Claim 34 words

The osmotic system for continuously dispensing an agent according to claim 49 wherein the laminated wall comprises a lamina next to the compartment that is essentially non-erodible and inert in the presence of agent.

Claim 56

Dependent Claim 34 words

The osmotic system for continuously dispensing an agent according to claim 49 wherein the laminated wall comprises a lamina distant from the compartment that is essentially non-erodible and inert in the environment of use.

Claim 57

Dependent Claim 19 words

The osmotic system for continuously dispensing an agent according to claim 49 wherein the laminated wall comprises three laminae.

Claim 58

Dependent Claim 42 words

The osmotic system for continuously dispensing an agent according to claim 49 wherein the agent has limited solubility in the fluid and is mixed with an osmotically effective compound that exhibits an osmotic pressure gradient across the laminated wall against the fluid.

Claim 59

Dependent Claim 32 words

The osmotic system for continuously dispensing an agent according to claim 49 wherein the inner lamina is a member selected from the group consisting of cellulose ethers, cellulose esters, polyurethanes and polyamides.

Claim 60

Dependent Claim 227 words

An osmotic system for the continuous dispensing of an active agent to an environment of use comprising: a. a shaped laminated wall comprising at least two laminae comprising one lamina made of a multiplicity of materials and one lamina made of a semipermeable material, said laminae forming a laminated wall that is permeable to the passage of an external fluid and substantially impermeable to the passage of agent with the wall surrounding and forming; b. a compartment containing an active agent; c. a passageway through the wall communicating with the compartment and the exterior of the system for dispensing agent from the system; and d. wherein in operation when the system is placed in the environment of use, fluid from the environment is continuously imbided through the laminated wall, having a total thickness h t , into the compartment in a tendency towards osmotic equilibrium at a rate proportional to the fluid transmission rate (kπ) t of the laminated wall which rate is governed by the following equation: ##EQU6## wherein h 1 , h 2 and h n are the thickness of the individual lamina, and (kπ) 1 , (kπ) 2 and (kπ) n are the fluid transmission rates for the respective laminae, said imbibed fluid continuously dissolving agent that is dispensed from the system at a controlled and continuous rate over a prolonged period of time.

Claim 61

Dependent Claim 227 words

An osmotic system for the continuous dispensing of an active agent to an environment of use comprising: a. a shaped laminated wall comprising at least two laminae comprising one lamina made of a multiplicity of materials and one lamina made of a semipermeable material, said laminae forming a laminated wall that is permeable to the passage of an external fluid and substantially impermeable to the passage of agent with the wall surrounding and forming; b. a compartment containing an active agent; c. a passageway through the wall communicating with the compartment and the exterior of the system for dispensing agent from the system; and d. wherein in operation when the system is placed in the environment of use, fluid from the environment is continuously imbided through the laminated wall, having a total thickness h t , into the compartment in a tendency towards osmotic equilibrium at a rate proportional to the fluid transmission rate (kπ) t of the laminated wall which rate is governed by the following equation: ##EQU6## wherein h 1 , h 2 and h n are the thickness of the individual lamina, and (kπ) 1 , (kπ) 2 and (kπ) n are the fluid transmission rates for the respective laminae, said imbibed fluid continuously dissolving agent that is dispensed from the system at a controlled and continuous rate over a prolonged period of time.

Claim 62

Dependent Claim 36 words

An osmotic system for continuously dispensing an agent according to claim 56 wherein the laminated wall comprises a lamina that is substantially impermeable to agent in the compartment and to compounds in the environment of use.

Claim 63

Dependent Claim 43 words

An osmotic system for continuously dispensing an agent according to claim 56 wherein the laminated wall comprises a lamina formed of a multiplicity of materials and positioned next to the compartment, said lamina being essentially non-erodible and inert in the presence of agent.

Claim 64

Dependent Claim 42 words

An osmotic system for continuously dispensing an agent according to claim 56 wherein the laminated wall comprises a lamina formed of a semipermeable material and positioned next to the compartment, said lamina being essentially non-erodible and inert in the presence of agent.

Claim 65

Dependent Claim 43 words

An osmotic system for continuously dispensing an agent according to claim 56 wherein the laminated wall comprises a lamina formed of a multiplicity of materials and positioned distant from the compartment, said lamina being essentially non-erodible and inert in the environment of use.

Claim 66

Dependent Claim 42 words

An osmotic system for continuously dispensing an agent according to claim 56 wherein the laminated wall comprises a lamina formed of a semipermeable material and positioned distant from the compartment, said lamina being essentially non-erodible and inert in the environment of use.

Claim 67

Dependent Claim 19 words

An osmotic system for continuously dispensing an agent according to claim 56 wherein the laminated wall comprises three laminae.

Claim 68

Dependent Claim 42 words

An osmotic system for continuously dispensing an agent according to claim 56 wherein the agent has limited solubility in the fluid and is mixed with an osmotically effective compound that exhibits an osmotic pressure gradient across the laminated wall against the fluid.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1980-02-22	1980-08-23	1981-02-22	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	1984-02-22	1984-08-23	1985-02-22	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	1988-02-22	1988-08-23	1989-02-22	$7700.00	Window Closed / Lapsed

Osmotic system having laminar arrangement for programming delivery of active agent

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