Osmotic system with distribution zone for dispensing beneficial agent
First Claim
1. A laminate useful for manufacturing a device for dispensing a beneficial agent to a fluid environment of use, said laminate comprising a first lamina formed of a member selected from the group consisting of cellulose acylate, cellulose diacylate and cellulose triacylate, a third lamina spaced distant from the first lamina, said third lamina formed of a composition comprising a polymer and a pore-former selected from the group consisting of carbohydrates and salts dispersed in the polymer, which polymer is a member selected from the group consisting of cellulose acylate, cellulose discylate and cellulose triacylate, and a second lamina positioned between the first and third lamina which second lamina is formed of a member selected from the group consisting of essentially salt and carbohydrate soluble in the fluid present in the environment of use.
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Abstract
An osmotic system is disclosed for dispensing a beneficial agent. The system comprises (1) a first wall of a semipermeable material that surrounds a compartment containing a drug formulation, and has a passageway through the wall for releasing agent from the compartment, (2) a second wall positioned distant from the first wall, said second wall a microporous or hydrogel material that extends around the first wall, and (3) a distribution zone interposed between the first and second wall and initially housing a compound soluble in an external fluid that enters the system.
In operation, agent is dispensed from the system by fluid passing through the second wall into the zone from which fluid is further being imbibed through the first wall into the compartment forming a solution that is released through the passageway into the zone, and then through the second wall to the exterior of the system.
761 Citations
22 Claims
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1. A laminate useful for manufacturing a device for dispensing a beneficial agent to a fluid environment of use, said laminate comprising a first lamina formed of a member selected from the group consisting of cellulose acylate, cellulose diacylate and cellulose triacylate, a third lamina spaced distant from the first lamina, said third lamina formed of a composition comprising a polymer and a pore-former selected from the group consisting of carbohydrates and salts dispersed in the polymer, which polymer is a member selected from the group consisting of cellulose acylate, cellulose discylate and cellulose triacylate, and a second lamina positioned between the first and third lamina which second lamina is formed of a member selected from the group consisting of essentially salt and carbohydrate soluble in the fluid present in the environment of use.
- 2. A three-layered laminate useful for manufacturing a device for dispensing a drug to a biological fluid environment of use, said laminate comprising a first lamina formed of a semipermeable polymer permeable to the passage of drug, a second lamina in laminar arrangement with the first lamina, said second lamina formed of a member selected from the group consisting of a carbohydrate, an organic and inorganic salt, and a third lamina in laminar arrangement with the second lamina, said third lamina formed of a polymer having a micropore forming agent distributed therein, which agent is soluble in the biological fluid and when the laminate is in the environment of use, the agent is leached from the polymer to form a microporous polymer.
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5. A laminate useful for manufacturing a device for dispensing a drug to a biological environment of use, said laminate comprising a first lamina formed of a member selected from the group consisting essentially of a cellulose acylate, cellulose diacylate and cellulose triacylate, a second lamina laminated to the first lamina, said second lamina consisting essentially of a member selected from the group consisting of an aqueous and biological fluid soluble carbohydrate and salt, and a third lamina laminated to the second lamina, said third lamina formed of a hydrophilic polymer that maintains its physical and chemical integrity in the environment of use, and which hydrophilic polymer has a pore-forming agent dispersed therein.
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6. An osmotic system for dispensing a beneficial agent to an environment of use, said system comprising:
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(a) a first wall formed a semipermeable material permeable to the passage of fluid present in the environment of use and substantially impermeable to the passage of beneficial agent;
a second wall formed of a polymer that maintains its physical and chemical integrity during the dispensing period and contains a pore forming agent dispersed therein, said second wall spaced distant and around the first wall; and
, a layer formed of a compound soluble in fluid that enters the compartment positioned between the first and second walls;
said walls surrounding with the first wall facing;(b) a compartment; (c) a beneficial agent housed in the compartment; and
,(d) a passageway in the first wall communicating the compartment with the layer. - View Dependent Claims (7, 8, 9, 10, 11, 12)
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13. An osmotic system for dispensing a beneficial agent to a fluid environment of use, said system comprising:
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(a) (1) a first wall formed of a semipermeable polymer permeable to the passage of fluid and substantially impermeable to the passage of beneficial agent, (2) a second wall formed of a hydrophilic hydrogel that maintains its physical and chemical integrity in the environment of use and during the dispensing of beneficial agent, said second wall in spaced relation from and extended around the first wall, and (3) a layer formed of a compound soluble in fluid that enters the system positioned between the first and second walls;
said wall surrounding with the first wall facing;(b) a compartment; (c) a beneficial agent housed in the compartment; and
,(d) a passageway in the first wall connecting the compartment with the layer.
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14. An osmotic therapeutic system sized, shaped and adapted for dispensing a drug to a biological environment of use, said therapeutic system comprising:
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(a) a pair of walls, said pair comprising (1) an inside wall formed of a semipermeable material permeable to the passage of a biological fluid and substantially impermeable to the passage of drug, (2) an outside wall spaced distant and around the inside wall, said outside wall formed of a polymer that keeps its physical and chemical integrity during the dispensing period and has a micropore forming agent dispersed therein;
(3) a distribution zone between the inside and outside walls, said zone housing a compound that is soluble in fluid that enters the system; and
, wherein the walls surround and form with the inside wall facing;(b) a compartment; (c) a drug selected from the group consisting of locally acting and systemically acting drugs housed in the compartment; and
,(d) a passageway in the inside wall communicating with the compartment and the zone between the walls. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22)
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Specification