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NZ748176B2 - Dispensing device and pharmaceutical composition for the treatment of rhinitis - Google Patents

Dispensing device and pharmaceutical composition for the treatment of rhinitis Download PDF

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Publication number
NZ748176B2
NZ748176B2 NZ748176A NZ74817618A NZ748176B2 NZ 748176 B2 NZ748176 B2 NZ 748176B2 NZ 748176 A NZ748176 A NZ 748176A NZ 74817618 A NZ74817618 A NZ 74817618A NZ 748176 B2 NZ748176 B2 NZ 748176B2
Authority
NZ
New Zealand
Prior art keywords
pharmaceutical composition
dispensing device
groove
container
well
Prior art date
Application number
NZ748176A
Other versions
NZ748176A (en
Inventor
Piyush Agarwal
Rajesh Ankam
Vikram Mansingh Bhosale
Chandrakant Dhatrak
Ulhas R Dhuppad
Yashwant Gupta
Ashok Katkurwar
Patrick Keohane
Joshi Neelima Khairatkar
Abhay Kulkarni
Original Assignee
Glenmark Specialty Sa
Filing date
Publication date
Priority claimed from US15/636,120 external-priority patent/US10016443B2/en
Priority claimed from US15/842,063 external-priority patent/US10653661B2/en
Priority claimed from US15/903,597 external-priority patent/US10758550B2/en
Application filed by Glenmark Specialty Sa filed Critical Glenmark Specialty Sa
Priority claimed from PCT/US2018/040098 external-priority patent/WO2019006173A1/en
Publication of NZ748176A publication Critical patent/NZ748176A/en
Publication of NZ748176B2 publication Critical patent/NZ748176B2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0043—Nose
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/006—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/006—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
    • A61M11/007—Syringe-type or piston-type sprayers or atomisers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • A61M15/0025—Mouthpieces therefor with caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/08—Inhaling devices inserted into the nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
    • B05B11/10—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
    • B05B11/10—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle
    • B05B11/1042—Components or details

Abstract

nasal dispensing device (605) and pharmaceutical composition includes a container (610); a dispenser head (615) having at least a pump (619), a dispensing channel, and a dispensing orifice; a dip tube (650); and a pharmaceutical composition comprising mometasone, an ester thereof (e.g., mometasone furoate), or a salt thereof and olopatadine or its salt (e.g., olopatadine hydrochloride). The composition also comprises a hydrocolloid in an amount sufficient to inhibit phase separation for at least 24 hours when stored at 25 ± 2° C. and 60% ± 5% relative humidity. The container (610) has can have a conically shaped internal bottom (420), angled downwardly toward a center, the center located along a longitudinal axis of the container, and a further angularly deepened, hemispherically shaped, well (425), centrally located, with the dip tube (650) extending into the well (425). The well (425) includes a semi-circularly shaped groove (479) therein, the groove further deepening an internal bottom of the well, the groove laterally extending across the longitudinal axis of the container, at a point of intersection of the groove (479) and the longitudinal axis, where the bottom of the groove, at the longitudinal axis, is a low point of the internal bottom of the container (610). An optional cap (510) is provided that includes a sealing sleeve (530) communicating in a seal tight manner with a perimeter of a lateral wall of the dispenser head (615).

Claims (21)

WHAT IS CLAIMED IS:
1. A dispensing device and pharmaceutical composition for nasal administration to a human, comprising: a container having a conically shaped internal bottom, wherein the internal bottom is angled downwardly from a side of the container toward a center, the center located along a longitudinal axis of the container, the internal bottom including a further angularly deepened, hemispherically shaped, well centrally located about the longitudinal axis, said well including a semi-circularly shaped groove therein, the groove further deepening an internal bottom of the well, the groove laterally extending across the longitudinal axis of the container, at a point of intersection of the groove and the longitudinal axis, where the bottom of the groove, at the longitudinal axis, is a low point of the internal bottom of the container; a dispenser head for dispensing the pharmaceutical composition from the container, the dispenser head comprising at least a pump, a dispensing channel, and a dispensing orifice; a dip tube extending along the longitudinal axis of the container, the dip tube having a proximal end communicating with the dispenser head and an open distal end extending into the well; and an aqueous pharmaceutical composition in the container, the composition comprising about 0.001% w/w to about 0.075% w/w mometasone, an ester thereof, or a salt thereof in particulate form; about 0.5% w/w to about 0.8% w/w olopatadine or its salt in dissolved form; and a hydrocolloid in an amount sufficient to inhibit phase separation for at least 24 hours when stored at 25 ± 2° C. and 60% ± 5% relative humidity.
2. The dispensing device and pharmaceutical composition of claim 1, wherein the open distal end of the dip tube extends to a top of the groove.
3. The dispensing device and pharmaceutical composition of claim 1 or claim 2, wherein a dimension of the groove, further deepening the internal bottom of the well, does not affect an external bottom of the well, as the dimension is within a wall thickness of the bottom of the well.
4. The dispensing device and pharmaceutical composition of claim 1, wherein the groove further deepens an internal bottom of the well in a dimension greater than a wall thickness of the bottom of the well, thereby requiring modification of an external bottom of at least the well, wherein a support bead, with the groove therein, extends from at least an external bottom of the well, the support bead also extending across the longitudinal axis of the container.
5. The dispensing device and pharmaceutical composition of claim 4, wherein the open distal end of the dip tube extends into the groove or is located at a top of the groove.
6. The dispensing device and pharmaceutical composition of any one of claims 1 to 5, wherein the dispensing device dispenses about 100 µl of the composition per actuation, wherein a single actuation dispenses about 665 mcg of olopatadine and about 25 mcg or about 50 mcg of mometasone.
7. The dispensing device and pharmaceutical composition of any one of claims 1 to 6, wherein the dispenser head is defined exteriorly by at least an end wall and a lateral wall, the end wall including the dispensing orifice; the dispensing device further including a cap releasably attachable to the dispenser head for covering at least the dispensing orifice, the cap including a sealing sleeve, extending from an interior surface of the cap, that communicates in a seal tight manner with a perimeter of the lateral wall of the dispenser head.
8. The dispensing device and pharmaceutical composition of claim 7, wherein an inner diameter of a distal end of the sealing sleeve is smaller than an exterior diameter of the lateral wall of the dispenser head, at a point of communication of the sealing sleeve with the lateral wall, to create the seal tight manner when the cap is in a closed position, whereby the distal end of the sealing sleeve is radially deformed.
9. The dispensing device and pharmaceutical composition of any one of claims 1 to 8, wherein the pharmaceutical composition is capable of providing relief from symptoms of allergic rhinitis upon delivery from the dispensing device to a patient suffering from allergic rhinitis.
10. The dispensing device and pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises about 0.025% w/w mometasone furoate, about 0.665% w/w olopatadine hydrochloride, about 0.5% w/w carboxymethyl cellulose sodium, about 1.2% w/w mixture of microcrystalline cellulose and carboxymethyl cellulose sodium, about 0.02% w/w benzalkonium chloride, about 0.4% w/w sodium chloride, about 0.01% w/w di- sodium edetate, about 0.94% w/w sodium phosphate heptahydrate, and about 0.01% w/w polysorbate 80.
11. The dispensing device and pharmaceutical composition of claim 1, wherein the dispenser head is defined exteriorly by at least an end wall and a lateral wall, the end wall including the dispensing orifice; and wherein the dispensing device and pharmaceutical composition further comprise: a cap releasably attachable to the dispenser head for covering at least the dispensing orifice, the cap including a sealing sleeve, extending from an interior surface of the cap, that communicates in a seal tight manner with a perimeter of the lateral wall of the dispenser head.
12. The dispensing device and pharmaceutical composition of claim 11, wherein the sealing sleeve extends from a top inside wall of the cap.
13. The dispensing device and pharmaceutical composition of claim 12, wherein an inner diameter of a distal end of the sealing sleeve is smaller than an exterior diameter of the lateral wall of the dispenser head, at a point of communication of the sealing sleeve with the lateral wall, to create the seal tight manner when the cap is in the closed position, whereby the distal end of the sealing sleeve is radially deformed.
14. The dispensing device and pharmaceutical composition of claim 12, wherein the sealing sleeve has a wall thickness that decreases as the sealing sleeve extends away from the top inside wall of the cap.
15. The dispensing device and pharmaceutical composition of any one of claims 11 to 14, wherein the cap includes, on an interior thereof, one or more protruding tabs that snap fit against the lateral wall of the dispenser head to hold the cap securely on the dispenser head in the closed position.
16. The dispensing device and pharmaceutical composition of any one of claims 11 to 15, wherein the pharmaceutical composition has a pH of about 3.3- 4.1, and an osmolality in the range of about 200 mOsm/kg to about 400 mOsm/kg.
17. The dispensing device and pharmaceutical composition of any one of claims 11 to 16, wherein the dispensing device dispenses about 100 µl of the composition per actuation, wherein a single actuation dispenses about 665 mcg of olopatadine hydrochloride and about 25 mcg or about 50 mcg of mometasone furoate.
18. The dispensing device and pharmaceutical composition of claim 1, wherein the open distal end of the dip tube extends to a bottom of the groove, at the longitudinal axis.
19. The dispensing device and pharmaceutical composition for nasal administration to a human subject of claim 1, further comprising: - 0.025 % w/w mometasone furoate in particulate form; - 0.665 % w/w olopatadine hydrochloride in dissolved form; wherein, - the pharmaceutical composition has a pH between 3.3 to 4.1.
20. The dispensing device and pharmaceutical composition of claim 19, wherein each spray of pharmaceutical composition provides (i) 25µg mometasone furoate and (ii) 665µg olopatadine hydrochloride.
21. The dispensing device and pharmaceutical composition of claim 19 or claim 20, wherein the pharmaceutical composition has a pH between 3.5 to 3.9.
NZ748176A 2018-06-28 Dispensing device and pharmaceutical composition for the treatment of rhinitis NZ748176B2 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US15/636,120 US10016443B2 (en) 2013-10-04 2017-06-28 Treatment of allergic rhinitis using a combination of mometasone and olopatadine
US201715691500A 2017-08-30 2017-08-30
US201715716661A 2017-09-27 2017-09-27
US15/842,063 US10653661B2 (en) 2013-10-04 2017-12-14 Treatment of allergic rhinitis using a combination of mometasone and olopatadine
US15/903,597 US10758550B2 (en) 2013-10-04 2018-02-23 Treatment of allergic rhinitis using a combination of mometasone and olopatadine
IN201821014426 2018-04-16
PCT/US2018/040098 WO2019006173A1 (en) 2017-06-28 2018-06-28 Dispensing device and pharmaceutical composition for the treatment of rhinitis

Publications (2)

Publication Number Publication Date
NZ748176A NZ748176A (en) 2024-08-30
NZ748176B2 true NZ748176B2 (en) 2024-12-03

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