# US 2014/0190866 A1 · Kit comprising a packaging material and a solid pharmaceutical or nutraceutical product contained in the packaging material

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- Number: US 2014/0190866 A1
- Document ID: US20140190866A1
- Status: Published application
- Kind: A1
- Application number: 14/240,848
- Filed: 2012-09-04
- Published: 2014-07-10
- Earliest claimed: 2011-09-05
- Assignees: Siegfried Aktiengesellschaft
- Inventors: Peter Demel
- Web page: https://patentgrep.com/patent/US20140190866A1

## CPC

- A61J 1/03: for pills or tablets (containers for pills or tablets with special dispensing means therefor B65D83/04)
- A61K 31/138: Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine (atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377)
- A61K 31/225: Polycarboxylic acids
- A61K 31/245: Amino benzoic acid types, e.g. procaine, novocaine (salicylic acid esters A61K31/60)
- A61K 31/4152: having oxo groups directly attached to the heterocyclic ring, e.g. antipyrine, phenylbutazone, sulfinpyrazone
- A61K 31/47: Quinolines; Isoquinolines
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- B32B 27/08: of synthetic resin
- B32B 27/34: comprising polyamides
- B32B 27/36: comprising polyesters
- B32B 27/38: comprising epoxy resins
- B32B 2250/02: 2 layers
- B32B 2250/24: All layers being polymeric
- B32B 2439/40: Closed containers
- B32B 2439/46: Bags
- B32B 2439/60: Bottles
- B32B 2439/70: Food packaging
- B32B 2439/80: Medical packaging
- B65D 65/38: Packaging materials of special type or form
- B65D 81/24: Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants (with thermal insulation B65D81/38)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- B32B: LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES

## Abstract

A kit including a packaging material and a solid pharmaceutical or nutraceutical product, and in particular for a solid, opioid-based pharmaceutical product. The packaging material has an inner surface and an outer surface that avoids contamination of the product. At least that part of the inner surface, which is exposed to the pharmaceutical or nutraceutical product, is made of or covered with an inert material selected from the group made of polyamide, polyethylene terephthalate and epoxy resin-coated aluminium. The solid pharmaceutical or nutraceutical product is either a solid, opioid-based pharmaceutical product or is selected from the group made of acemetacin, amitriptyline, amobarbital, butalbital, carbachol, citric acid, dexmethylphenidate, fluoxetine, mephobarbital, metamizole, methadone, methylphenidate, methylphenobarbital, nicotine, nifedipine, oxprenolol, oxyconazole, pentobarbital, phenobarbital, phentermine, primidone, proparacaine, propoxyphene, secobarbital, selegiline, tetrahydropapaverine, trimethobenzamide, and mixtures thereof.

## Claims

### Claim at position 1

1-15. (canceled)

### Claim 16

Kit comprising a packaging material and a solid pharmaceutical or nutraceutical product contained in the packaging material, the packaging material having an inner surface and an outer surface, characterized in that at least that part of the inner surface, which is exposed to the pharmaceutical or nutraceutical product, is made of or covered with an inert material selected from the group consisting of polyamide, polyethylene terephthalate and epoxy resin-coated aluminium,
and in that the solid pharmaceutical or nutraceutical product is either a solid, opioid-based pharmaceutical product or is selected from the group consisting of acemetacin, amitriptyline, amobarbital, butalbital, carbachol, citric acid, dexmethylphenidate, fluoxetine, mephobarbital, metamizole, methadone, methylphenidate, methylphenobarbital, nicotine, nifedipine, oxprenolol, oxyconazole, pentobarbital, phenobarbital, phentermine, primidone, proparacaine, propoxyphene, secobarbital, selegiline, tetrahydropapaverine, trimethobenzamide, and mixtures thereof.

### Claim 17 (depends on 16)

Kit according to claim 16, wherein the solid, opioid-based pharmaceutical product comprises an opioid, which is selected from the group consisting of buprenorphine, codeine, hydrocodone, hydromorphone, methylnaltrexone, morphine, naloxone, naltrexone, oxycodone, oxymorphone, and mixtures thereof.

### Claim 18 (depends on 17)

Kit according to claim 17, wherein the solid, opioid-based pharmaceutical product comprises buprenorphine, buprenorphine hydrochloride, codeine phosphate, hydrocodone bitartrate, hydromorphone hydrochloride, methylnaltrexone bromide, morphine sulphate, naloxone, naloxone hydrochloride, naltrexone, naltrexone hydrochloride, oxycodone hydrochloride, and/or oxymorphone hydrochloride.

### Claim 19 (depends on 16)

Kit according to claim 16, wherein the solid pharmaceutical or nutraceutical product comprises acemetacin, amitriptyline hydrochloride, butalbital, carbachol, citric acid, dexmethylphenidate hydrochloride, fluoxetine hydrochloride, methadone, methadone hydrochloride, methylphenidate, methylphenidate hydrochloride, methylphenobarbital, mephobarbital, nicotine bitartrate, nifedipine, oxyconazole nitrate, oxprenolol hydrochloride, phentermine, phentermine hydrochloride, primidone, proparacaine hydrochloride, propoxyphene hydrochloride, propoxyphene napsylate, selegiline hydrochloride, sodium amobarbital, sodium metamizole, sodium pentobarbital, sodium phenobarbital, sodium secobarbital, trimethobenzamide hydrochloride, and/or (R)-tetrahydropapaverine.

### Claim 20 (depends on 16)

Kit according to claim 16, wherein the inert material is PA6.6, PA6 and/or PA11.

### Claim 21 (depends on 16)

Kit according to claim 16, wherein the entire inner surface of the packaging material is made of or covered with the inert material.

### Claim 22 (depends on 16)

Kit according to claim 16, wherien the inert material has a thickness of at least 5 μm, preferably of at least 10 μm, more preferably of at least 20 μm, and most preferably of about 30 μm.

### Claim 23 (depends on 16)

Kit according to claim 16, wherein the inner surface of the packaging material is made of polyamide and the outer surface is made of polyethylene.

### Claim 24 (depends on 16)

Kit according to claim 16 wherein the packaging material has a three-dimensional form or shape.

### Claim 25 (depends on 16)

Kit according to claim 16 wherein the packaging material is in the form of a bottle, in particular a screw cap bottle, or a bag, a box, a bag-in-box packaging, a basket, a can, an envelope, a tube or a container, in particular an infusion container.

### Claim 26 (depends on 16)

Kit according to claim 16 wherein the pharmaceutical or nutraceutical product is sealed into the packaging material, preferably under sterile conditions.

### Claim 27

A method of a packaging material for the packaging of a solid pharmaceutical or nutraceutical product, in particular during transport, storage and/or handling, the packaging material having an inner surface and an outer surface, characterized in that at least that part of the inner surface, which is exposed to the pharmaceutical or nutraceutical product, is made of or covered with an inert material selected from the group consisting of polyamide, polyethylene terephthalate and epoxy resin-coated aluminium,
and in that the solid pharmaceutical or nutraceutical product is either a solid, opioid-based pharmaceutical product or is selected from the group consisting of acemetacin, amitriptyline, amobarbital, butalbital, carbachol, citric acid, dexmethylphenidate, fluoxetine, mephobarbital, metamizole, methadone, methylphenidate, methylphenobarbital, nicotine, nifedipine, oxprenolol, oxyconazole, pentobarbital, phenobarbital, phentermine, primidone, proparacaine, propoxyphene, secobarbital, selegiline, tetrahydropapaverine, trimethobenzamide, and mixtures thereof.

### Claim 28 (depends on 27)

The method of the packaging material according to claim 27, wherein the solid, opioid-based pharmaceutical product comprises an opioid, which is selected from the group consisting of buprenorphine, codeine, hydrocodone, methylnaltrexone, morphine, hydromorphone, naloxone, naltrexone, oxycodone, oxymorphone, and mixtures thereof.

### Claim 29 (depends on 28)

The method of the packaging material according to claim 28, wherein the solid, opioid-based pharmaceutical product comprises buprenorphine, buprenorphine hydrochloride, codeine phosphate, hydrocodone bitartrate, hydromorphone hydrochloride, methylnaltrexone bromide, morphine sulphate, naloxone, naloxone hydrochloride, naltrexone, naltrexone hydrochloride, oxycodone hydrochloride, and/oxymorphone hydrochloride.
