CA2451106A1 - Sequential drug delivery systems - Google Patents

Sequential drug delivery systems Download PDF

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Publication number
CA2451106A1
CA2451106A1 CA002451106A CA2451106A CA2451106A1 CA 2451106 A1 CA2451106 A1 CA 2451106A1 CA 002451106 A CA002451106 A CA 002451106A CA 2451106 A CA2451106 A CA 2451106A CA 2451106 A1 CA2451106 A1 CA 2451106A1
Authority
CA
Canada
Prior art keywords
active ingredient
adjusting
dosage form
substances
substance
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
Application number
CA002451106A
Other languages
French (fr)
Other versions
CA2451106C (en
Inventor
S. Indiran Pather
John Hontz
John M. Siebert
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.)
Cima Labs Inc
Original Assignee
Individual
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
Application filed by Individual filed Critical Individual
Publication of CA2451106A1 publication Critical patent/CA2451106A1/en
Application granted granted Critical
Publication of CA2451106C publication Critical patent/CA2451106C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • 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
    • A61K31/48—Ergoline derivatives, e.g. lysergic acid, ergotamine
    • 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
    • A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
    • A61K9/025—Suppositories; Bougies; Bases therefor; Ovules characterised by shape or structure, e.g. hollow layered, coated
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50

Abstract

The invention relates to methods and composition for improving absorption and dissolution of active ingredients of drugs. The invention provides a method of administration of an active ingredient to a mammal through a transmucosal route that includes delivering the active ingredient to a desired site in a body of the mammal, and, sequentially, at the desired site, promoting dissolution and absorption of the active ingredient. In a preferred embodiment, the ph of the localized environment of the active ingredient is sequentially modified to promote dissolution and absorption.

Claims (47)

1. A method of administration of an active ingredient to a mammal through a transmucosal route, said method comprising:

a. delivering said active ingredient to a desired site in a body of said mammal; and, sequentially, at said desired site, i. adjusting a localized environment of said active ingredient to promote dissolution of said active ingredient, ii. adjusting said localized environment to promote absorption of said active ingredient.
2. The method of claim 1, wherein said active ingredient is delivered in a dosage form having a first portion and a second portion;

said step of adjusting said localized environment to promote said dissolution comprising releasing said first portion of said dosage form;

said step of adjusting said localized environment to promote said absorption comprising releasing said second portion of said dosage form.
3. The method of claim 2, wherein said desired site is selected from the group consisting of a site of administration and a site of absorption.
4. The method of claim 2, wherein said first portion includes one or more first substances that promote said dissolution of said active ingredient, said one or more first substances selected from the group consisting of pH-adjusting substances, surface-active compounds, pharmaceutically-acceptable solvents and enveloping additives;

said second portion including one or more second substances that promote absorption, said one or more second substances selected from the group consisting of pH-adjusting substances, effervescent penetration enhancers, non-effervescent penetration enhancers and bioadhesives.
5. The method of claim 2, wherein said first portion of said dosage form includes a first pH-adjusting substance thereby said active ingredient attains a first state of dissociation that promotes dissolution;

said second portion of said dosage form including a second pH-adjusting substance thereby said active ingredient attains a second state of dissociation that promotes absorption.
6. The method of claim 5, wherein said first and said second pH-adjusting substances are respectively an acid and a base.
7. The method of claim 5, wherein said first and said second pH-adjusting substances are respectively a base and an acid.
8. The method of claim 5, wherein said first and said second pH-adjusting substance are respectively a base and a base.
9. The method of claim 5, wherein said first and said second pH-adjusting substances are respectively an acid and an acid.
10. The method of claim 1, wherein said transmucosal route is selected from the group consisting of buccal, sublingual, gingival, gastrointestinal, rectal, vaginal, and nasal routes.
11. The method of claim 1, wherein said active ingredient is selected from the group consisting of analgesics, anti-inflammatories, antipyretics, antibiotics, antimicrobials, laxatives, anorexics, antihistamines, antiasthmatics, antidiuretics, antiflatuents, antimigraine agents, antispasmodics, sedatives, antihyperactives, antihypertensives, tranquilizers, decongestants, beta blockers, peptides, proteins, and oligonucleotides.
12. The method of claim 5, wherein said dosage form includes means for said sequential release of said first portion and said second portion, said means for sequential release selected from the group consisting of coatings, membranes, matrix materials, pre-cursors of active ingredients and pre-cursors of pH-adjusting substances.
13. The method of claim 5, wherein said second portion of said dosage form comprises said second pH-adjusting substance dispersed in a controlled release matrix material.
14. The method of claim 5, wherein said first portion of said dosage form includes said active ingredient.
15. The method of claim 5, wherein said second portion of said dosage form comprises said second pH-adjusting substance surrounded by a coating, whereby said first pH-adjusting substance is peripheral to said coating in said dosage form.
16. The method of claim 15, wherein said active ingredient is peripheral to said coating in said dosage form.
17. The method of claim 5, wherein said second portion of said dosage form includes said second pH-adjusting substance surrounded by a membrane, said first pH-adjusting substance being peripheral to said membrane.
18. The method of claim 17, wherein said active ingredient is peripheral to said membrane in said dosage form.
19. A method for administering an active ingredient via a transmucosal route in a mammal, comprising administering said active ingredient in a dosage form with a first pH-adjusting substance and a second pH-adjusting substance thereby the localized environment of the active ingredient attains a first pH and then a second pH, said first pH

promoting dissolution of said active ingredient and said second pH promoting absorption of said active ingredient.
20. The method of claim 19, wherein said first pH-adjusting substance attains peak activity in the localized environment of the active ingredient before said second pH-adjusting substance attains peak activity in the localized environment of the active ingredient.
21. The method of claim 19, wherein said first and said second pH-adjusting substances are respectively an acid and a base.
22. The method of claim 19, wherein said first and said second pH-adjusting substances are respectively a base and an acid.
23. The method of claim 19, wherein said first and said second pH-adjusting substance are respectively a base and a base.
24. The method of claim 19, wherein said first and said second pH-adjusting substances are respectively an acid and an acid.
25. The method of claim 19, wherein said transmucosal route is selected from the group consisting of buccal, sublingual, gingival, gastrointestinal, rectal, vaginal, and nasal.
26. The method of claim 19, wherein said active ingredient is selected from the group consisting of analgesics, anti-inflammatories, antipyretics, antibiotics, antimicrobials, laxatives, anorexics, antihistamines, antiasthmatics, antidiuretics, antiflatuents, antimigraine agents, antispasmodics, sedatives, antihyperactives, antihypertensives, tranquilizers, decongestants, beta blockers, peptides, proteins, and oligonucleotides.
27. The method of claim 19, wherein said administering step includes providing said second pH-adjusting substance dispersed in a controlled release matrix material in said dosage form.
28. The method of claim 27, wherein said active ingredient is peripheral to said controlled release matrix material in said dosage form.
29. The method of claim 19, wherein said administering step includes providing said second pH-adjusting substance surrounded by a coating, wherein said first pH-adjusting substance is peripheral to said coating in said dosage form.
30. The method of claim 29, wherein said active ingredient is peripheral to said coating in said dosage form.
31. The method of claim 19, wherein said administering step includes providing said second pH-adjusting substance surrounded by a membrane, wherein said first pH-adjusting substance is peripheral to said membrane in said dosage form.
32. The method of claim 31, wherein said active ingredient is peripheral to said membrane in said dosage form.
33. A pharmaceutical composition comprising an active ingredient in a dosage form comprising a first portion, a second portion and means for sequential release of said first portion and said second portion at a desired site; said first portion including one or more first substances that adjust a localized environment of said active ingredient at said desired site to promote dissolution of said active ingredient; said second portion including one or more second substances that adjust said localized environment of said active ingredient at said desired site to promote absorption of said active ingredient.
34. The composition of claim 33, wherein said first substance comprises a first pH-adjusting substance, said second substance comprises a second pH-adjusting substance, and said means for sequential release are means for sequentially controlling the activity of said pH-adjusting substances so that said first pH-adjusting substance attains peak activity in the localized environment of the active ingredient before said second pH-adjusting substance attains peak activity in the localized environment; whereby the localized environment of the active ingredient attains a first pH and then a second pH, said first pH promoting dissolution of said active ingredient and said second pH promoting absorption of said active ingredient.
35. The pharmaceutical composition of claim 34, wherein said first and second pH-adjusting substances are respectively an acid and a base.
36. The pharmaceutical composition of claim 34, wherein said first and said second pH-adjusting substances are respectively a base and an acid.
37. The pharmaceutical composition of claim 34, wherein said first and said second pH-adjusting substance are respectively a base and a base.
38. The pharmaceutical composition of claim 34, wherein said first and second pH-adjusting substances are respectively an acid and an acid.
39. The pharmaceutical composition of claim 33, wherein said means for sequential release are selected from the group consisting of coatings, membranes, matrix materials, active ingredients pre-cursors and precursors of pH-adjusting substances.
40. The pharmaceutical composition of claim 34, wherein said means for sequentially controlling the activity of said pH-adjusting substances comprises at least one coating that surrounds said second pH-adjusting substance, said first pH-adjusting substance being peripheral to said coating in said dosage form.
41. The pharmaceutical composition of claim 40, wherein said active ingredient is peripheral to said coating in said dosage form.
42. The pharmaceutical composition of claim 34, wherein said means for sequentially controlling the activity of said pH-adjusting substances comprises a controlled release matrix material in said dosage form, said second pH-adjusting substance being dispersed in said controlled release matrix material, and said first pH-adjusting substance being peripheral to said controlled release matrix material in said dosage form.
43. The pharmaceutical composition of claim 42, wherein said active ingredient is peripheral to said matrix material in said dosage form.
44. The pharmaceutical composition of claim 34, wherein said means for sequentially controlling the peak activities of said pH-adjusting substances comprises at least one membrane in said dosage form that surrounds said second pH-adjusting substance, said first pH-adjusting substance being peripheral to said membrane in said dosage form.
45. The pharmaceutical composition of claim 44, wherein said active ingredient is peripheral to said membrane in said dosage form.
46. The pharmaceutical composition of claim 33, wherein said active ingredient is selected from the group consisting of analgesics, anti-inflammatories, antipyretics, antibiotics, antimicrobials, laxatives, anorexics, antihistamines, antiasthmatics, antidiuretics, antiflatuents, antimigraine agents, antispasmodics, sedatives, antihyperactives, antihypertensives, tranquilizers, decongestants, beta blockers, peptides, proteins, and oligonucleotides.
47 47. The pharmaceutical composition of claim 33, wherein said one or more first substances are selected from the group consisting of pH-adjusting substances, surface-active compounds, pharmaceutically-acceptable solvents and enveloping additives, said one or more second substances are selected from the group consisting of pH-adjusting substances, effervescent penetration enhancers and non-effervescent penetration enhancers.
CA002451106A 2001-07-10 2002-07-10 Sequential drug delivery systems Expired - Fee Related CA2451106C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/901,983 2001-07-10
US09/901,983 US20030068356A1 (en) 2001-07-10 2001-07-10 Sequential drug delivery systems
PCT/US2002/021796 WO2003005944A1 (en) 2001-07-10 2002-07-10 Sequential drug delivery systems

Publications (2)

Publication Number Publication Date
CA2451106A1 true CA2451106A1 (en) 2003-01-23
CA2451106C CA2451106C (en) 2009-12-22

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CA002451106A Expired - Fee Related CA2451106C (en) 2001-07-10 2002-07-10 Sequential drug delivery systems

Country Status (11)

Country Link
US (3) US20030068356A1 (en)
EP (2) EP1406568B1 (en)
JP (1) JP4617081B2 (en)
AT (1) ATE363261T1 (en)
AU (2) AU2002320385B2 (en)
CA (1) CA2451106C (en)
DE (1) DE60220408T2 (en)
DK (1) DK1406568T3 (en)
ES (2) ES2286263T3 (en)
HK (1) HK1106126A1 (en)
WO (1) WO2003005944A1 (en)

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Also Published As

Publication number Publication date
EP1818029B1 (en) 2016-09-07
EP1406568A1 (en) 2004-04-14
DE60220408T2 (en) 2008-01-31
AU2008203464A1 (en) 2008-08-21
HK1106126A1 (en) 2008-03-07
JP2004534839A (en) 2004-11-18
CA2451106C (en) 2009-12-22
ES2286263T3 (en) 2007-12-01
ATE363261T1 (en) 2007-06-15
JP4617081B2 (en) 2011-01-19
ES2604780T3 (en) 2017-03-09
AU2008203464B2 (en) 2010-07-01
WO2003005944A1 (en) 2003-01-23
US7670617B2 (en) 2010-03-02
EP1818029A2 (en) 2007-08-15
EP1406568A4 (en) 2004-12-15
US20030232080A1 (en) 2003-12-18
US20050031677A1 (en) 2005-02-10
US20030068356A1 (en) 2003-04-10
DE60220408D1 (en) 2007-07-12
AU2002320385B2 (en) 2008-05-01
EP1406568B1 (en) 2007-05-30
EP1818029A3 (en) 2008-06-11
DK1406568T3 (en) 2007-10-01

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