IP Library › Granted Patent US 10,842,802
Granted Patent B2
US 10,842,802 · App. 13/890,173 · Granted Nov 24, 2020

Controlled release pharmaceutical dosage forms

Inventors: Sajeev Chandran (Pune, IN); Shirishkumar Kulkarni (Pune, IN); Pravin Meghrajji Bhutada (Pune, IN); Ashish Ashokrao Deshmukh (Pune, IN); Douglas Bakan (Scottsdale, AZ); Mitchell Wortzman (Scottsdale, AZ)
Assignee: MEDICIS PHARMACEUTICAL CORPORATION
A61K31/65A61K9/0065A61K9/209A61K9/2086
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Quick Facts
Patent No.
US 10,842,802
App. No.
13/890,173
Granted
Nov 24, 2020
Kind
B2
Abstract

The present disclosure provides novel controlled release pharmaceutical dosage form, methods of making the same, and methods of using the same to treat dermatological conditions.

Claims (29)

1. A method for treating acne, rosacea, or a combination thereof comprising administering to a patient in need thereof a controlled release doxycycline dosage form comprising an amount of immediate release doxycycline, wherein said doxycycline dosage form has a t max that is at least about 1.15 times greater than the t max of an immediate release doxycycline dosage form of equivalent strength.

2. The method of claim 1 , wherein said doxycycline dosage form has a t max that is at least about 1.2 times greater than the t max of an immediate release doxycycline dosage form of equivalent strength.

3. The method of claim 1 , wherein said doxycycline dosage form has a t max that is at least about 1.5 times greater than the t max of an immediate release doxycycline dosage form of equivalent strength.

4. The method of claim 1 , wherein said doxycycline dosage form has a t max that is at least about 1.7 times greater than the t max of an immediate release doxycycline dosage form of equivalent strength.

5. A method for treating acne, rosacea, or a combination thereof comprising administering to a patient in need thereof a controlled release doxycycline pharmaceutical dosage form comprising an amount of immediate release doxycycline, wherein said controlled release doxycycline pharmaceutical dosage form has a mean C max that is at least about 70% that of an immediate release doxycycline dosage form of equivalent strength and has at least one of an AUC 0-48 h or an AUC 0-96 h that is at least about 85% of an immediate release doxycycline dosage form of equivalent strength, wherein the amount of immediate release doxycycline is contained in an immediate release doxycycline layer.

6. The method of claim 5 , wherein the immediate release doxycycline layer is an immediate release doxycycline overcoat.

7. The method of claim 1 , wherein the amount of immediate release doxycycline is contained in an immediate release doxycycline overcoat.

8. The method of claim 1 , wherein the amount of immediate release doxycycline is contained in an immediate release doxycycline layer.

9. The method of claim 6 , wherein the controlled release doxycycline pharmaceutical dosage form comprises:

a controlled release doxycycline layer, a swellable and/or floating layer, an expandable porous coating, and an immediate release doxycycline overcoat, or

a swellable controlled release doxycycline core, a permeable/expandable porous coating, and an immediate release doxycycline overcoat, or

a controlled release doxycycline layer, an inert swellable/bioadhesive layer, and an immediate release doxycycline overcoat.

10. The method of claim 6 , wherein the controlled release doxycycline pharmaceutical dosage form comprises:

a controlled release doxycycline layer, a swellable and/or floating layer, an expandable porous coating, and an immediate release doxycycline overcoat, wherein the controlled release doxycycline layer includes a first amount of doxycycline and the immediate release doxycycline layer includes a second amount of doxycycline, wherein the first amount of doxycycline is from 5 to 15 weight % doxycycline based on the total weight of the dosage form and the second amount of doxycycline is from 0.5 to 3.2 weight % doxycycline based on the total weight of the dosage form, or

a swellable controlled release doxycycline core, a permeable/expandable porous coating, and an immediate release doxycycline overcoat, wherein the swellable controlled release doxycycline core comprises from 5 to 15 weight % doxycycline based on the total weight of the dosage form, and the immediate release doxycycline overcoat comprises from 0.5 to 3.2 weight % doxycycline based on the total weight of the dosage form, or

a controlled release doxycycline layer, an inert swellable/bioadhesive layer, and an immediate release doxycycline overcoat, wherein the controlled release doxycycline layer comprises from 5 to 15 weight % doxycycline based on the total weight of the dosage form, and the immediate release doxycycline overcoat comprises from 0.5 to 3.2 weight % doxycycline based on the total weight of the dosage form.

11. The method of claim 6 , wherein the dosage form comprises a controlled release doxycycline layer, a swellable and/or floating layer, an expandable porous coating, and an immediate release doxycycline overcoat, wherein the controlled release doxycycline layer includes a first amount of doxycycline and the immediate release doxycycline layer includes a second amount of doxycycline, wherein the first amount of doxycycline is from 5 to 15 weight % doxycycline based on the total weight of the dosage form and the second amount of doxycycline is from 0.5 to 3.2 weight % doxycycline based on the total weight of the dosage form.

12. The method of claim 6 , wherein the dosage form comprises a swellable controlled release doxycycline core, a permeable/expandable porous coating, and an immediate release doxycycline overcoat, wherein the swellable controlled release doxycycline core comprises from 5 to 15 weight % doxycycline based on the total weight of the dosage form, and the immediate release doxycycline overcoat comprises from 0.5 to 3.2 weight % doxycycline based on the total weight of the dosage form.

13. The method of claim 6 , wherein the dosage form comprises a controlled release doxycycline layer, an inert swellable/bioadhesive layer, and an immediate release doxycycline overcoat, wherein the controlled release doxycycline layer comprises from 5 to 15 weight % doxycycline based on the total weight of the dosage form, and the immediate release doxycycline overcoat comprises from 0.5 to 3.2 weight % doxycycline based on the total weight of the dosage form.

14. The method of claim 6 , wherein the controlled release doxycycline dosage form has at least one of an AUC 0-48 h or an AUC 0-96 h that is at least about 90% that of the immediate release doxycycline dosage form of equivalent strength.

15. The method of claim 6 , wherein the controlled release doxycycline dosage form has at least one of an AUC 0-48 h or an AUC 0-96 h that is at least about 95% that of the immediate release doxycycline dosage form of equivalent strength.

16. The method of claim 6 , wherein the controlled release doxycycline dosage form has at least one of an AUC 0-48 h or an AUC 0-96 h that is at least about 97% that of the immediate release doxycycline dosage form of equivalent strength.

17. The method of claim 6 , wherein the controlled release doxycycline pharmaceutical dosage form has a mean C max that is at least about 80% that of an immediate release doxycycline dosage form of equivalent strength.

18. The method of claim 6 , wherein the controlled release doxycycline pharmaceutical dosage form has a mean C max that is at least about 90% that of an immediate release doxycycline dosage form of equivalent strength.

19. The method of claim 6 , wherein the controlled release doxycycline pharmaceutical dosage form has a mean C max that is at least about 95% that of an immediate release doxycycline dosage form of equivalent strength.

20. The method of claim 7 , wherein the controlled release doxycycline pharmaceutical dosage form comprises:

a controlled release doxycycline layer, a swellable and/or floating layer, an expandable porous coating, and an immediate release doxycycline overcoat, wherein the controlled release doxycycline layer includes a first amount of doxycycline and the immediate release doxycycline layer includes a second amount of doxycycline, wherein the first amount of doxycycline is from 5 to 15 weight % doxycycline based on the total weight of the dosage form and the second amount of doxycycline is from 0.5 to 3.2 weight % doxycycline based on the total weight of the dosage form, or

a swellable controlled release doxycycline core, a permeable/expandable porous coating, and an immediate release doxycycline overcoat, wherein the swellable controlled release doxycycline core comprises from 5 to 15 weight % doxycycline based on the total weight of the dosage form, and the immediate release doxycycline overcoat comprises from 0.5 to 3.2 weight % doxycycline based on the total weight of the dosage form, or

a controlled release doxycycline layer, an inert swellable/bioadhesive layer, and an immediate release doxycycline overcoat, wherein the controlled release doxycycline layer comprises from 5 to 15 weight % doxycycline based on the total weight of the dosage form, and the immediate release doxycycline overcoat comprises from 0.5 to 3.2 weight % doxycycline based on the total weight of the dosage form.

Assignments (19)
RELEASE OF SECURITY INTEREST Recorded Nov 20, 2025
From: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
To: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH AMERICAS, INC.
Reel/Frame 073654/0242 →
RELEASE OF SECURITY INTEREST Recorded Nov 20, 2025
From: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
To: ATON PHARMA, INC.; BAUSCH & LOMB INCORPORATED; BAUSCH & LOMB PHARMA HOLDINGS CORP.; COMMONWEALTH LABORATORIES, LLC; DOW PHARMACEUTICAL SCIENCES, INC.; ECR PHARMACEUTICALS CO., INC.; LABORATOIRE CHAUVIN S.A.S.; MEDICIS PHARMACEUTICAL CORPORATION; ONPHARMA INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, LTD.; SALIX PHARMACEUTICALS, INC.; SANTARUS, INC.; SOLTA MEDICAL, INC.; SYNERGETICS USA, INC.; TECHNOLAS PERFECT VISION GMBH; VALEANT CANADA LP; VALEANT PHARMACEUTICALS INTERNATIONAL; VALEANT PHARMACEUTICALS INTERNATIONAL, INC.; VALEANT PHARMACEUTICALS NORTH AMERICA LLC; WIRRA IP PTY LIMITED; VALEANT PHARMA POLAND SP. Z O.O.; VALEANT PHARMACEUTICALS LUXEMBOURG S.A R.L.; VALEANT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 073637/0001 →
RELEASE OF SECURITY INTEREST Recorded Nov 20, 2025
From: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
To: BAUSCH HEALTH AMERICAS, INC.; BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.
Reel/Frame 073637/0126 →
U.S. PATENT SECURITY AGREEMENT Recorded Jun 13, 2025
From: MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; BAUSCH HEALTH US, LLC (F/K/A VALEANT PHARMACEUTICALS NORTH AMERICA LLC); PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SANTARUS, INC.; BAUSCH HEALTH AMERICAS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON
Reel/Frame 071564/0463 →
U.S. PATENT SECURITY AGREEMENT Recorded Jun 13, 2025
From: MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; BAUSCH HEALTH US, LLC (F/K/A VALEANT PHARMACEUTICALS NORTH AMERICA LLC); PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SANTARUS, INC.; BAUSCH HEALTH AMERICAS, INC.; SOLTA MEDICAL, INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 071566/0200 →
RELEASE OF SECURITY INTEREST Recorded Apr 8, 2025
From: BARCLAYS BANK PLC, AS COLLATERAL AGENT
To: SOLTA MEDICAL, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH IRELAND LIMITED (F/K/A/ VALEANT PHARMACEUTICALS IRELAND LIMITED); SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD; SANTARUS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; HUMAX PHARMACEUTICAL S.A.; SOLTA MEDICAL IRELAND LIMITED; BAUSCH & LOMB MEXICO, S.A. DE C.V.; BAUSCH+LOMB OPS B.V.; BAUSCH HEALTH AMERICAS, INC.; BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH HOLDCO LIMITED; BAUSCH HEALTH MAGYARORSZAG KFT (A/K/A BAUSCH HEALTH HUNGARY LLC); BAUSCH HEALTH POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA (F/K/A VALEANT PHARMA POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA); BAUSCH HEALTH US, LLC; BAUSCH HEALTH, CANADA INC. / SANTE BAUSCH, CANADA INC.; ICN POLFA RZESZOW SPOLKA AKCYJNA (A/K/A ICN POLFA RZESZOW S.A.); ORAPHARMA, INC.; PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA SPOLKA AKCYJNA (A/K/A PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA S.A.); SOLTA MEDICAL DUTCH HOLDINGS B.V.; V-BAC HOLDING CORP.; VRX HOLDCO LLC; 1261229 B.C. LTD.; 1530065 B.C. LTD.
Reel/Frame 070778/0199 →
SECURITY AGREEMENT (SECOND LIEN) Recorded Oct 5, 2022
From: BAUSCH HEALTH US, LLC; BAUSCH HEALTH AMERICAS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061606/0468 →
SECURITY AGREEMENT (FIRST LIEN) Recorded Oct 4, 2022
From: BAUSCH HEALTH US, LLC; BAUSCH HEALTH AMERICAS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061595/0066 →
SECURITY AGREEMENT Recorded Feb 10, 2022
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH AMERICAS, INC.
To: THE BANK OF NEW YORK MELLON
Reel/Frame 059121/0001 →
SECURITY INTEREST Recorded Jun 8, 2021
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH AMERICAS, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 056811/0814 →
SECURITY INTEREST Recorded Mar 11, 2019
From: BAUSCH HEALTH AMERICAS, INC.; BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 048556/0758 →
SECURITY INTEREST Recorded Feb 26, 2018
From: ATON PHARMA, INC.; BAUSCH & LOMB INCORPORATED; BAUSCH & LOMB PHARMA HOLDINGS CORP.; COMMONWEALTH LABORATORIES, LLC; DOW PHARMACEUTICAL SCIENCES, INC.; ECR PHARMACEUTICALS CO., INC.; LABORATOIRE CHAUVIN S.A.S.; MEDICIS PHARMACEUTICAL CORPORATION; ONPHARMA INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, LTD.; SALIX PHARMACEUTICALS, INC.; SANTARUS, INC.; SOLTA MEDICAL, INC.; SYNERGETICS USA, INC.; TECHNOLAS PERFECT VISION GMBH; VALEANT CANADA LP; VALEANT PHARMACEUTICALS INTERNATIONAL; VALEANT PHARMACEUTICALS INTERNATIONAL, INC.; VALEANT PHARMACEUTICALS NORTH AMERICA LLC; WIRRA IP PTY LIMITED; VALEANT PHARMA POLAND SP. Z O.O.; VALEANT PHARMACEUTICALS LUXEMBOURG S.A R.L.; VALEANT PHARMACEUTICALS IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON, AS COLLATERAL AGENT
Reel/Frame 045444/0634 →
SECURITY INTEREST Recorded Feb 26, 2018
From: ATON PHARMA, INC.; BAUSCH & LOMB INCORPORATED; BAUSCH & LOMB PHARMA HOLDINGS CORP.; COMMONWEALTH LABORATORIES, LLC; DOW PHARMACEUTICAL SCIENCES, INC.; ECR PHARMACEUTICALS CO., INC.; LABORATOIRE CHAUVIN S.A.S.; MEDICIS PHARMACEUTICAL CORPORATION; ONPHARMA INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, LTD.; SALIX PHARMACEUTICALS, INC.; SANTARUS, INC.; SOLTA MEDICAL, INC.; SYNERGETICS USA, INC.; TECHNOLAS PERFECT VISION GMBH; VALEANT CANADA LP; VALEANT PHARMACEUTICALS INTERNATIONAL; VALEANT PHARMACEUTICALS INTERNATIONAL, INC.; VALEANT PHARMACEUTICALS NORTH AMERICA LLC; WIRRA IP PTY LIMITED; VALEANT PHARMA POLAND SP. Z O.O.; VALEANT PHARMACEUTICALS LUXEMBOURG S.A R.L.; VALEANT PHARMACEUTICALS IRELAND LIMITED
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 045444/0299 →
SECURITY INTEREST Recorded Jul 19, 2017
From: MEDICIS PHARMACEUTICAL CORPORATION
To: THE BANK OF NEW YORK MELLON
Reel/Frame 043239/0675 →
SECURITY INTEREST Recorded Jul 18, 2016
From: ATON PHARMA, INC.; BAUSCH & LOMB INCORPORATED; BAUSH & LOMB PHARMA HOLDINGS CORP.; DENDREON PHARMACEUTICALS, INC.; DOW PHARMACEUTICAL SCIENCES, INC.; MEDICIS PHARMACEUTICAL CORPORATION; OBAGI MEDICAL PRODUCTS, INC.; OMP, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD; SANTARUS, INC.; SOLTA MEDICAL, INC.; VALEANT CANADA LP, BY ITS GENERAL PARTNER VALEANT CANADA GP LIMITED; VALEANT PHARMACEUTICALS INTERNATIONAL, INC.; VALEANT HOLDINGS IRELAND (AS SUCCESSOR TO VALEANT INTERNATIONAL BERMUDA); VALEANT PHARMACEUTICALS NORTH AMERICA LLC; VALEANT PHARMACEUTICALS IRELAND
To: BARCLAYS BANK PLC
Reel/Frame 039380/0385 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 4, 2014
From: WORTZMAN, MITCHELL
To: MEDICIS PHARMACEUTICAL CORPORATION
Reel/Frame 034160/0399 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 20, 2014
From: BAKAN, DOUGLAS A.
To: MEDICIS PHARMACEUTICAL CORPORATION
Reel/Frame 033983/0101 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 24, 2014
From: LUPIN LIMITED
To: MEDICIS PHARMACEUTICAL CORPORATION
Reel/Frame 033812/0577 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 24, 2014
From: CHANDRAN, SAJEEV; KULKARNI, SHIRISH; DESHMUKH, ASHISH ASHOKRAO; BHUTADA, PRAVIN MEGHRAJJI
To: LUPIN LIMITED
Reel/Frame 033805/0966 →
Priority Claims (1)
IN 0304/KOL/2013 · Mar 15, 2013 · national
Continuity (1)
Related Publication 20140274970A1 · Sep 18, 2014