CA2794042A1 - Fast dissolving drug delivery systems - Google Patents

Fast dissolving drug delivery systems Download PDF

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Publication number
CA2794042A1
CA2794042A1 CA2794042A CA2794042A CA2794042A1 CA 2794042 A1 CA2794042 A1 CA 2794042A1 CA 2794042 A CA2794042 A CA 2794042A CA 2794042 A CA2794042 A CA 2794042A CA 2794042 A1 CA2794042 A1 CA 2794042A1
Authority
CA
Canada
Prior art keywords
fast dissolving
film according
oral
dissolving film
difficulties
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.)
Abandoned
Application number
CA2794042A
Other languages
French (fr)
Inventor
Dominique Costantini
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
APR Applied Pharma Research SA
Original Assignee
Bioalliance Pharma SA
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from US12/729,735 external-priority patent/US20110237563A1/en
Priority claimed from EP10305288A external-priority patent/EP2377526A1/en
Application filed by Bioalliance Pharma SA filed Critical Bioalliance Pharma SA
Publication of CA2794042A1 publication Critical patent/CA2794042A1/en
Abandoned legal-status Critical Current

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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics

Abstract

The present invention related to the administration of bioactive agents via oral fast dispersing/dissolving drug delivery systems for treating illnesses of patient with critical buccal condition, leading to difficulties in swallowing oral medicine forms and thus difficulties in treating said illnesses. Particularly, the present invention discloses the administration of bioactive agents via oral fast dispersing/dissolving drug delivery systems for treating illnesses of patient with dysphagia and/or odynophagia and/or aspiration risk. Another aspect of the present invention is the administration of bioactive agents via oral fast dispersing/dissolving drug delivery systems for the treatment of dysphagia and/or odynophagia and/or aspiration risk.

Claims (14)

1. An oral fast dissolving film comprising bioactive agent, a hydrophilic binder and/or a water-soluble diluents for treating illnesses of patient undergoing critical buccal conditions leading to difficulties in swallowing oral medicine forms, wherein added water is not required to facilitate the dissolution of said fast dissolving film.
2. An oral fast dissolving film according to claim 1 wherein critical buccal conditions leading to difficulties in swallowing oral medicine forms is dysphagia.
3. An oral fast dissolving film according to claim 1 or 2 wherein critical buccal conditions leading to difficulties in swallowing oral medicine forms is aspiration risk.
4. An oral fast dissolving film according to any one of claim 1 to 3 wherein critical buccal conditions leading to difficulties in swallowing oral medicine forms is odynophagia.
5. An oral fast dissolving film according to any one of claim 1 to 4 wherein critical buccal conditions leading to difficulties in swallowing oral medicine forms is due to mucositis induced by chemotherapy and/or radiotherapy.
6. An oral fast dissolving film according to any one of claim 1 to 5 f wherein critical buccal conditions leading to difficulties in swallowing oral medicine forms is due to reduced salivary flow.
7. An oral fast dissolving film according to any one of claim 1 to 6 wherein critical buccal conditions leading to difficulties in swallowing oral medicine forms is due head and neck or oesophageal cancer.
8. An oral fast dissolving film according to any one of claim 1 to 7 for the treatment of dysphagia.
9. An oral fast dissolving film according to any one of claim 1 to 8 wherein the bioactive agent is selected from: donepezil hydrochloride; ondansetron; ondansetron base;
desloratadine; olanzapine; risperidone; rivastigmine tartrate; sildenafil;
vardenafil;
galantamine; diclofenac potassium; buprenorphine HCl; naloxone HCl dehydrate;
alprazolam; clonazepam; diazepam; lorazepam; sumatriptan; eletriptan;
rizatriptan;
zolmitriptan; naratriptan; almotriptan; frovatriptan; cetirizine hydrochloride; loratadine;
ambroxol hydrochloride; apomorphine; ascorbic acid; betamethasone; caffeine;
dextromethorphan; glimepiride; hydrocortisone; ketotifen; loperamide;
meclozine;
melatonin; neramexane; piroxicam; sodium picosulfate; and zinc histidine; or a pharmaceutically acceptable salt thereof; or a combination thereof.
10. An oral fast dissolving film according to any one of claim 1 to 9 wherein the film comprises from 0.05% to 50% by weight of said bioactive agent.
11. An oral fast dissolving film according to any one of claim 1 to 10 wherein the film comprises from 40% to 80% by weight of one or more ingredients that constitute a hydrophilic binder and a water soluble diluent.
12. An oral fast dissolving film according to any one of claim 11 wherein the hydrophilic binder is Polyvinylalcohol.
13. An oral fast dissolving film according to any one of claim 11 or 12 wherein the water-soluble diluents is rice starch.
14. An oral fast dissolving film according to any one of claim 1 to 13 comprising Ondansetron Base, Polyvinylalcohol, PolyEthylene Glycol, Glycerol anhydrous, Rice starch, Polysorbate, Ethanol and Purified Water.
CA2794042A 2010-03-23 2011-03-23 Fast dissolving drug delivery systems Abandoned CA2794042A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US12/729,735 US20110237563A1 (en) 2010-03-23 2010-03-23 Fast dissolving drug delivery systems
EP10305288A EP2377526A1 (en) 2010-03-23 2010-03-23 Fast dissolving drug delivery systems
US12/729,735 2010-03-23
EP10305288.2 2010-03-23
PCT/EP2011/054482 WO2011117313A1 (en) 2010-03-23 2011-03-23 Fast dissolving drug delivery systems

Publications (1)

Publication Number Publication Date
CA2794042A1 true CA2794042A1 (en) 2011-09-29

Family

ID=44070534

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2794042A Abandoned CA2794042A1 (en) 2010-03-23 2011-03-23 Fast dissolving drug delivery systems

Country Status (9)

Country Link
EP (1) EP2549988A1 (en)
KR (1) KR20130012067A (en)
CN (1) CN103025321A (en)
AU (1) AU2011231645A1 (en)
BR (1) BR112012024092A2 (en)
CA (1) CA2794042A1 (en)
RU (1) RU2560693C2 (en)
WO (1) WO2011117313A1 (en)
ZA (1) ZA201207900B (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020014776A1 (en) * 2018-07-15 2020-01-23 Rapid Dose Therapeutics Corp. Cannabinoid oral dispersible film strip

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CN102920683B (en) * 2012-06-11 2013-08-14 江苏豪森药业股份有限公司 Olanzapine oral instant membrane
CN102860997A (en) * 2012-09-28 2013-01-09 天津市聚星康华医药科技有限公司 Ondansetron oral cavity instant membrane capable of sheltering taste and preparation method thereof
CN102846581A (en) * 2012-09-28 2013-01-02 天津市聚星康华医药科技有限公司 Ambroxol hydrochloride oral fast-dissolving film and preparation method thereof
CA2886573C (en) * 2012-10-11 2019-04-02 Stephen Lim Chin Beng Solid dosage form
CN103432105A (en) * 2013-09-02 2013-12-11 天津市聚星康华医药科技有限公司 Meclozine oral film and preparation method thereof
CN104666280B (en) * 2015-03-21 2017-10-13 合肥华方医药科技有限公司 A kind of Glipizide oral cavity dissolving films and preparation method thereof
CN104958279A (en) * 2015-06-27 2015-10-07 万特制药(海南)有限公司 Loratadine oral quickly-soluble film and preparation method thereof
CN104940174A (en) * 2015-07-23 2015-09-30 合肥华方医药科技有限公司 Preparation method of donepezil oral fast dissolving film
DE102017112527B4 (en) * 2017-06-07 2019-01-03 Lts Lohmann Therapie-Systeme Ag Fast disintegrating foam wafers with a high basis weight
CN111770748A (en) * 2017-12-29 2020-10-13 拉克斯顿医疗股份公司 Drug delivery system
CN108078962A (en) * 2018-01-29 2018-05-29 中国药科大学 A kind of instant film of donepezil hydrochloride orally and preparation method thereof
CN108142940B (en) * 2018-02-05 2021-05-14 中山大学附属第三医院（中山大学肝脏病医院） Soft tablet for promoting swallowing and preparation method thereof
KR20230159643A (en) 2019-01-31 2023-11-21 닛세이 에이. 에스. 비 기카이 가부시키가이샤 Resin container manufacturing apparatus, temperature adjusting device, resin container manufacturing method, and temperature adjusting method
KR20210111848A (en) 2019-01-31 2021-09-13 닛세이 에이. 에스. 비 기카이 가부시키가이샤 Preform temperature control device and temperature control method, and resin molded container manufacturing device and manufacturing method
KR20230047511A (en) 2019-01-31 2023-04-07 닛세이 에이. 에스. 비 기카이 가부시키가이샤 Production device and production method for resin containers
WO2020158920A1 (en) 2019-01-31 2020-08-06 日精エー・エス・ビー機械株式会社 Device and method for producing resin container
US11179331B1 (en) 2020-04-21 2021-11-23 Cure Pharmaceutcai Holding Corp Oral soluble film containing sildenafil citrate

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RU2351315C2 (en) * 2003-07-24 2009-04-10 Смитклайн Бичам Корпорейшн Films, dissolving in mouth cavity
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020014776A1 (en) * 2018-07-15 2020-01-23 Rapid Dose Therapeutics Corp. Cannabinoid oral dispersible film strip

Also Published As

Publication number Publication date
EP2549988A1 (en) 2013-01-30
CN103025321A (en) 2013-04-03
AU2011231645A2 (en) 2012-12-20
ZA201207900B (en) 2013-06-26
RU2012144848A (en) 2014-04-27
WO2011117313A1 (en) 2011-09-29
KR20130012067A (en) 2013-01-31
BR112012024092A2 (en) 2016-09-06
AU2011231645A1 (en) 2012-10-18
RU2560693C2 (en) 2015-08-20

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Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20160212

FZDE Discontinued

Effective date: 20200903