Pharmaceutical compositions

• US 10,064,856 B2
• Filed: 08/22/2017
• Issued: 09/04/2018
• Est. Priority Date: 01/09/2008
• Status: Active Grant

• Current Assignee: LOCL Pharma, Inc. (Charleston Laboratories, Inc.)
• Original Assignee: LOCL Pharma, Inc. (Charleston Laboratories, Inc.)
• Inventors: Bosse, Paul, Ameling, John, Schachtel, Bernard, Takigiku, Ray
• Primary Examiner(s): Tran, Susan T
• Application Number:
  US15/683,635
• Publication Number:
  US 20170348303A1
• Time in Patent Office: 378 Days
• Field of Search: None
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/24 having an amino or nitro group
• CPC Class Codes: A61K 31/403 condensed with carbocyclic rings, e.g. carbazole
• CPC Class Codes: A61K 31/404 Indoles, e.g. pindolol
• CPC Class Codes: A61K 31/4196 1,2,4-Triazoles
• CPC Class Codes: A61K 31/422 not condensed and containing further heterocyclic rings
• CPC Class Codes: A61K 31/437 the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
• CPC Class Codes: A61K 31/454 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/515 Barbituric acids; Derivatives thereof, e.g. sodium pentobarbital
• CPC Class Codes: A61K 31/522 having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
• CPC Class Codes: A61K 31/5415 ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0056 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
• CPC Class Codes: A61K 9/1694 resulting in granules or microspheres of the matrix type containing more than 5% of excipient
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/2054 : Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/2086 : Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat active cores with a complete drug-free outer coat A61K9/28
• CPC Class Codes: A61K 9/209 : containing drug in at least two layers or in the core and in at least one outer layer
• CPC Class Codes: A61K 9/4808 : characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084
• CPC Class Codes: A61K 9/5084 : Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs tablets containing such a mixture A61K9/2077
• CPC Class Codes: A61P 1/08 : for nausea, cinetosis or vertigo; Antiemetics
• CPC Class Codes: A61P 25/04 : Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/06 : Antimigraine agents
• CPC Class Codes: A61P 25/08 : Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 29/02 : without antiinflammatory effect
• CPC Class Codes: A61P 39/00 : General protective or antinoxious agents
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system

Abstract

Methods and compositions are provided which comprise effective amounts of an analgesic to treat a subject, including reducing or eliminating an adverse effect associated with the analgesic.

Claims

1. A solid oral pharmaceutical composition, wherein the solid oral pharmaceutical composition comprises:

a. a first matrix, wherein the first matrix comprises an effective amount of a first pharmaceutically active agent for treating or preventing a condition in a subject in need thereof; and

b. a second matrix, wherein the second matrix comprises an effective amount of a second pharmaceutically active agent for preventing or reducing a secondary symptom associated with the condition, and wherein the second matrix is an immediate release matrix,

wherein the first pharmaceutically active agent comprises a serotonin receptor agonist that comprises an ergot, and wherein the ergot comprises ergotamine, methysergide, or zonisamide.

2. A solid oral pharmaceutical composition, wherein the solid oral pharmaceutical composition comprises:

a. a first matrix, wherein the first matrix comprises an effective amount of a first pharmaceutically active agent for treating or preventing a condition in a subject in need thereof; and

b. a second matrix, wherein the second matrix comprises an effective amount of a second pharmaceutically active agent for preventing or reducing a secondary symptom associated with the condition, and wherein the second matrix is an immediate release matrix,

wherein the first pharmaceutically active agent comprises a serotonin receptor agonist that comprises a triptan, and wherein the triptan comprises naratriptan, almotriptan, sumatriptan, zolmitriptan, eletriptan, frovatriptan, or rizatriptan.

3. A solid oral pharmaceutical composition, wherein the solid oral pharmaceutical composition comprises:

a. a first matrix, wherein the first matrix comprises an effective amount of a first pharmaceutically active agent for treating or preventing a condition in a subject in need thereof; and

b. a second matrix, wherein the second matrix comprises an effective amount of a second pharmaceutically active agent for preventing or reducing a secondary symptom associated with the condition, and wherein the second matrix is an immediate release matrix,

wherein the first pharmaceutically active agent comprises a beta blocker, and wherein the beta blocker comprises acebutolol, arotinolol, atenolol, betaxolol, bisoprolol, butoxamine, carvedilol, carteolol, esmolol, carteolol, carvedilol, labetalol, levobunolol, mepindolol, metoprolol, nebivolol, nadolol, oxprenolol, penbutolol, propranolol, pindolol, sotalol, or timolol.

4. A solid oral pharmaceutical composition, wherein the solid oral pharmaceutical composition comprises:

a. a first matrix, wherein the first matrix comprises an effective amount of a first pharmaceutically active agent for treating or preventing a condition in a subject in need thereof; and

b. a second matrix, wherein the second matrix comprises an effective amount of a second pharmaceutically active agent for preventing or reducing a secondary symptom associated with the condition, and wherein the second matrix is an immediate release matrix,

wherein the first pharmaceutically active agent comprises a vasoconstrictor, and wherein the vasoconstrictor comprises isometheptene mucate, caffeine, pseudoephedrine, ergine, methylphenidate, or psilocybin.

5. A solid oral pharmaceutical composition, wherein the solid oral pharmaceutical composition comprises:

a. a first matrix, wherein the first matrix comprises an effective amount of a first pharmaceutically active agent for treating or preventing a condition in a subject in need thereof; and

b. a second matrix, wherein the second matrix comprises an effective amount of a second pharmaceutically active agent for preventing or reducing a secondary symptom associated with the condition, and wherein the second matrix is an immediate release matrix,

wherein the first pharmaceutically active agent comprises a anti-platelet agent, and wherein the anti-platelet agent comprises acetylsalycyclic acid, clopidogrel, ticlopidine, cilostazol, abciximab, eptifibatide, tirofiban defibrotide, or dipyridamole.

6. A solid oral pharmaceutical composition, wherein the solid oral pharmaceutical composition comprises:

a. a first matrix, wherein the first matrix comprises an effective amount of a first pharmaceutically active agent for treating or preventing a condition in a subject in need thereof; and

b. a second matrix, wherein the second matrix comprises an effective amount of a second pharmaceutically active agent for preventing or reducing a secondary symptom associated with the condition, and wherein the second matrix is an immediate release matrix,

wherein the first pharmaceutically active agent comprises an anti-covulsant, and wherein the anti-convulsant comprises topiramate, divaprex, pehnobarbital, methlyphenobarbital, metharbital, barbexaclone, stiripentol, clobazam, clonazepam, clorazepate, diazepam, midazolam, lorazepam, nitrazepam, temazepam, nimetazepam, potassium bromide, felbamate, carbamazepine, oxcarbazepine, vigabatrin, progabide, tiagabine, gabapentin, prgabalin, ethotoin, phenytoin, mephenytoin, fosphenytoin, paramethadione, trimethadione, ethadione, beclaminde, primidone, brivaracetam, levetiracetam, seletracetam, ethsuximide, phesuximide, mesuximide, acetazolamide, sulthiame, methazolamide, zonisamide, lamotrigine, pheneturide, phenacemide, valpromide, or valnoctamide.

7. A solid oral pharmaceutical composition, wherein the solid oral pharmaceutical composition comprises:

a. a first matrix, wherein the first matrix comprises an effective amount of a first pharmaceutically active agent for treating or preventing a condition in a subject in need thereof; and

b. a second matrix, wherein the second matrix comprises an effective amount of a second pharmaceutically active agent for preventing or reducing a secondary symptom associated with the condition, and wherein the second matrix is an immediate release matrix,

wherein the first pharmaceutically active agent comprises a calcitonin-gene-related peptide (CGRP) receptor antagonist, and wherein the CGRP receptor antagonist comprises MK-0974, CGRP8-37, BIBN 4096 BS, quinine, nitrobenzamide, 4-oxobutanamide, a cyclopropane derivative, or a benzimidazolinyl piperidine.