CA2624110A1 - A rapidly-dissolving orally administrable wafer formulation - Google Patents
A rapidly-dissolving orally administrable wafer formulation Download PDFInfo
- Publication number
- CA2624110A1 CA2624110A1 CA 2624110 CA2624110A CA2624110A1 CA 2624110 A1 CA2624110 A1 CA 2624110A1 CA 2624110 CA2624110 CA 2624110 CA 2624110 A CA2624110 A CA 2624110A CA 2624110 A1 CA2624110 A1 CA 2624110A1
- Authority
- CA
- Canada
- Prior art keywords
- wafer
- agent
- gel
- film forming
- pharmaceutical agent
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
Abstract
An orally administrable wafer is provided comprising at least one physiologically acceptable film forming agent. The wafer is formed by mixing the film-forming agent with an aqueous solution to form a gel and exposing the gel to a plurality of heating and cooling cycles. The wafer is rapidly dissolving and suitable for administration of pharmaceutical agents.
Claims (24)
1. An orally administrable wafer comprising at least one physiologically acceptable film forming agent, wherein the film forming agent is dissolved in an aqueous solution and treated with heat to form a wafer that exhibits a dissolution rate of at least about 2 milligrams/sec in an aqueous environment.
2. A wafer as defined in claim 1, wherein the film forming agent is selected from the group consisting of pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, glycolide, polylactide, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl polymer, amylose, high amylose starch, hydroxypropylated high amylose starch, dextrin, pectin, chitin, chitosan, levan, elsinan and mixtures thereof.
3. A wafer as defined in claim 2, comprising the film forming agents pullalan, PEG, polyvinyl alcohol and carrageenan.
4. A wafer as defined in claim 1, additionally comprising a pharmaceutical agent.
5. A wafer as defined in claim 4, wherein the pharmaceutical agent is an analgesic.
6. A wafer as defined in claim 5, wherein the pharmaceutical agent is selected from the group consisting of morphine, heroin, hydromorphone, metophon, oxymorphone, levorphanol, codeine, hydrocodone, xycodone, nalorphine, naloxone, naltrexone and fentanyl.
7. A wafer as defined in claim 4, wherein the pharmaceutical agent is an anti-microbial agent.
8. A wafer as defined in claim 1, additionally comprising one or more compounds selected from the group consisting of: a plasticizing agent, a flavoring agent, a sulfur precipitating agent, a saliva stimulating agent, a cooling agent, a surfactant, a stabilizing agent, an emulsifying agent, a thickening agent, a binding agents, a coloring agent, a sweetener, and a fragrance.
9. An orally administrable wafer comprising at least one physiologically acceptable film forming agent, wherein said wafer is formed by mixing the film forming agent with an aqueous solution to form a gel and exposing the gel to a plurality of heating and cooling cycles.
10. A wafer as defined in claim 4, that exhibits a T max, of the agent on administration of the wafer to a patient of less than about 7 minutes.
11. A method of preparing an orally administrable wafer comprising the steps of:
1) mixing at least one physiologically acceptable film forming agent with an aqueous solution to form a gel; and 2) exposing the gel to a plurality of cycles, each cycle comprising heating and cooling, to transform the gel into a wafer.
1) mixing at least one physiologically acceptable film forming agent with an aqueous solution to form a gel; and 2) exposing the gel to a plurality of cycles, each cycle comprising heating and cooling, to transform the gel into a wafer.
12. A method as defined in claim 11, wherein each cycle comprises a period of heating up to a temperature within the range of 60 - 90 °C.
13. A method as defined in claim 11, wherein each cycle comprises a period of heating and a period of cooling, and each of said periods lasts about 5 - 15 s.
14. A method as defined in claim 11, comprising at least 3 cycles of heating and cooling.
15. A method as defined in claim 14, wherein the total time of the cycles is between about 1 and 2 minutes.
16. A method as defined in claim 11, comprising the additional step of adding a pharmaceutical agent dissolved in an aqueous solution to the gel prior to heating.
17. A method as defined in claim 16, wherein a measured amount of pharmaceutical agent is added to the gel to yield a wafer with a defined quantity of pharmaceutical agent therein.
18. A method as defined in claim 11, wherein the heating is achieved by exposure to microwaves.
19. An orally administrable wafer comprising a pharmaceutical agent and at least one physiologically acceptable film forming agent, wherein the pharmaceutical agent is present in a pre-defined quantity.
20. A wafer as defined in claim 19, having a dissolution rate of at least about 2 milligrams/sec in an aqueous environment.
21. A wafer as defined in claim 4, wherein the C max of the agent attained on administration of the wafer to a patient is at least about 25%.
22. A method of administering a pharmaceutical agent to a mammal comprising the step of orally administering to the mammal a wafer comprising the pharmaceutical agent, wherein said wafer comprises at least one physiologically acceptable film forming agent and the pharmaceutical agent and the wafer is characterized by a dissolution rate of at least about 2 mg/s in an aqueous environment.
23. A method as defined in claim 22, wherein the pharmaceutical agent treats pain.
24. A method as defined in claim 22, wherein the wafer is prepared by mixing at least one physiologically acceptable film forming agent with an aqueous solution to form a gel;
and exposing the gel to a plurality of cycles, each cycle comprising heating and cooling, to transform the gel into a wafer.
and exposing the gel to a plurality of cycles, each cycle comprising heating and cooling, to transform the gel into a wafer.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA2624110A CA2624110C (en) | 2008-03-27 | 2008-03-27 | A rapidly-dissolving orally administrable wafer formulation |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA2624110A CA2624110C (en) | 2008-03-27 | 2008-03-27 | A rapidly-dissolving orally administrable wafer formulation |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2624110A1 true CA2624110A1 (en) | 2008-11-14 |
CA2624110C CA2624110C (en) | 2010-11-09 |
Family
ID=39971178
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2624110A Active CA2624110C (en) | 2008-03-27 | 2008-03-27 | A rapidly-dissolving orally administrable wafer formulation |
Country Status (1)
Country | Link |
---|---|
CA (1) | CA2624110C (en) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11166912B2 (en) | 2016-03-03 | 2021-11-09 | Ctt Pharma Inc. | Orally administrable composition |
US11298336B2 (en) | 2019-05-30 | 2022-04-12 | Soluble Technologies, Inc. | Water soluble formulation |
US11786475B2 (en) | 2020-07-22 | 2023-10-17 | Soluble Technologies Inc. | Film-based dosage form |
-
2008
- 2008-03-27 CA CA2624110A patent/CA2624110C/en active Active
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11166912B2 (en) | 2016-03-03 | 2021-11-09 | Ctt Pharma Inc. | Orally administrable composition |
US11298336B2 (en) | 2019-05-30 | 2022-04-12 | Soluble Technologies, Inc. | Water soluble formulation |
US11786475B2 (en) | 2020-07-22 | 2023-10-17 | Soluble Technologies Inc. | Film-based dosage form |
Also Published As
Publication number | Publication date |
---|---|
CA2624110C (en) | 2010-11-09 |
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EEER | Examination request |