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
  • A61K9/0043—Nose
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
  • A61K36/534—Mentha (mint)
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
• • 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
• • 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
  • 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

Definitions

• the present invention relates to a formulation used as a nasal spray containing nigella oil.
• the present invention relates to a non-sterile formulation with natural content comprising nigella sativa oil aimed to be applied to the nasal mucosa for moisturizing the nasal mucosa and eliminating nasal congestion, that provides a protective barrier and reduces mucosal irritation, inflammation, edema and allergic rhinitis.
• noses Majority of human beings prefer to breathe through their noses. Breathing through the nose is essential for aerating auditory canal, for proper functioning of both olfactory and gustatory senses, as well as for moisturizing and heating the air. Nasal mucosa and nasal conchae assume an important role in moisturizing, heating and cleaning by filtering the air breathed through the nose. Thus, nose can generate air that is healthier for both our throat and for our lungs, thereby allowing them to function and helping in providing oxygen to the body. A congested nose means a body which is partially deprived of these functions.
• Nasal congestion is the blockage occurring in nasal passageways which emanates from swelling of nose, adjacent tissues and blood vessels with excessive volume of fluids. Rheum, also known as nasal discharge may or may not be observed together with nasal congestion. This problem may originate from any condition causing irritation on nasal tissues or inflammation. Infection, cold weather, allergens, air conditioning and ventilation systems are among the primary reasons causing this problem.
• Nasal congestion which frequently observed in otolaryngologic diseases as well as during seasonal changes is a problem that substantially affects the quality of life of human beings. Being unable to breathe freely may result in nasal and post-nasal drip, headache, snoring, morning fatigue, chronic fatigue and performance decrease during the day. As aforementioned problem may also inhibit hearing and speaking, it may also cause disorders such as ageusia and anosmia as well as frequently recurring throat infections.
• nasal decongestants or sprays Many of the commercially available nasal sprays function by inducing vasoconstriction, thereby reducing the volume therein. Thus, once the blood flow rate has decreased, blood cells causing edema cannot reach respective region, thereby ameliorating edema.
• Said nasal sprays which should be limited to short-term use, manifest severe side-effects including disrupting inflation-deflation cycle, causing addiction as well as damage in the nasal tissues and inducing chronic nasal congestions in case of long-term use. Furthermore, they also induce mild side-effects such as stinging, burning and dryness sensation during use.
• Process integrity for filtering, cleaning of the nasal mucosa may be disrupted with the damage caused to the mucosal structure.
• the use of nasal sprays of this type is also limited in patients with systemic diseases such as hypertension and glaucoma.
• cartilage tissue may become affected and damage may be observed in septums in case of long-term use.
• Active ingredients of oxymetazoline and xylometazoline are either used individually or in combination in commercially available nasal sprays for the treatment of nasal congestion.
• US patent application numbered US2006222718 relates to a stable aqueous solution prepared by using a combination of aforementioned agents and used for eliminating nasal congestions.
• Said application discloses a formulation that aims to improve the stability of active ingredients by using a zinc salt and a buffer salt and reduce side-effects stemming from undesired substances emerging due to degradation.
• US patent application numbered US6599883B1 relates to the use of nasal sprays containing xylitol for the treatment of upper respiratory infections and otitis.
• Xylitol produces desired effects by means of inhibiting and/or reducing growth and acid release of certain bacteria such as S. Mutans and Streptococcus pneumonia.
• US patent document numbered US 2014/0228304 A1 which belongs to the same applicant relates to the use of xylitol in combination with anti-mucosal compositions. It is stated that xylitol, as used in these combinations, alleviates side-effects such as dryness caused by anti-mucosal compositions.
• sesame seed oil that contains tocopherol which is capable of neutralizing ozone and nitrous oxides present in the air inhaled, and of preventing both tissue damage and inflammation is also well-known.
• nigella sativa oil which contains as much tocopherol as sesame seed oil does, provides significant reduction in symptoms of both allergic rhinitis and asthma when administered orally, it is stated that there are no studies discussing the topical administration of nigella sativa oil. In the study, isotonic sodium chloride solution and nigella sativa oil were administered separately to geriatric patients for a period of 2 weeks. There is a washout period of 3 weeks between aforementioned administration periods.
• Subjective symptoms including intranasal burning, congestion, itching and scabbing were evaluated on a visual analog scale and with a mucociliary function saccharine test. No significant differences were observed between the nasal use of both nigella sativa oil and isotonic saline solution for intranasal burning and itching symptoms at the end of the study period. Moreover, no changes were observed in terms of mucociliary clearance during any of said treatment periods. In contrast thereof, patients' symptoms of intranasal dryness, congestion and scabbing in geriatric group treated with nigella sativa oil showed significant relief when compared to patients who were administered isotonic saline solution.
• Patients included in the active group were treated with nigella sativa oil, while patients included in the control group were administered conventional cooking oil in the form of nasal drops for a period of 6 weeks. Subsequent to the 6-week treatment period, 100% of the patients with mild symptoms and who were included in the active group had complete symptom relief, 68.7% of the patients with moderate symptoms and who were included in the active group had complete relief of symptoms, while 25% of which showed alleviated symptoms, whereas, 58.3% of the patients with severe symptoms and who were included in the active group had complete symptom relief, while 25% of which had alleviated symptoms. 92.1 % of the total of patients included in the active group had full symptom relief or alleviated symptoms, while the rate for the control group remained at 30.1 %.
• the present application seeks to solve problems encountered in the state of the art.
• the inventive formulation disclosed in the present application allows for cleaning the upper respiratory tract, thereby removing microorganisms, allergens and irritants which may be potentially harmful to ear, nose and throat. Moreover, it further moisturizes and relieves the nose in nasal congestion, dryness and irritations stemming from dry weather, influenza, common cold and allergy by means of the moisturizing characteristics of essential oils present in its content.
• the present invention relates to a nasal spray for decongesting nasal obstructions and moisturizing nasal mucosa, that eliminates aforementioned disadvantages and meets respective requirements.
• a dry or congested nose cannot perform respiratory functions adequately. Accordingly, fluid of nasal mucosa may carry germs to ears, nose and throat. Since the inventive formulation will clear and decongests sinuses and nasal tracts once it is administered, it will accordingly remove microorganisms, allergens and irritants that may potentially be harmful to ears, nose and throat, and discharge them from the nose.
• the inventive formulation moisturizes and relieves the nose in nasal dryness and irritation cases which are caused either by dry air generated by air conditioners, ventilation systems and weather conditions or by influenza, common cold and allergies since it serves as a natural moisturizer by means of the essential oils present in its content.
• the inventive formulation further helps relieving the symptoms of allergic rhinitis by means of therapeutic effect of nigella sativa oil contained therein.
• the inventive formulation is formed from a mixture of purified water, nigella sativa oil, salt (NaCI), xylitol, xanthan gum, eucalyptus oil, peppermint oil and grapefruit seed extract. Active ingredients of eucalyptus and peppermint oils included in the inventive formulation are commonly used in formulations for decongesting nasal obstructions and alleviating allergic symptoms due to their potent decongestive effects. Xylitol is added to compositions in order to prevent nasal dryness caused by active ingredients particularly included in anti-mucosal compositions.
• Nigella sativa oil which is one of the active ingredients included in the inventive formulation has a therapeutic potential in the treatment of respiratory tract diseases due to its anti-inflammatory, anti-oxidant, anti-histaminic, anti-microbial and analgesic effects.
• Therapeutic effect of nigella sativa oil originates from tocopherol that neutralizes ozone and nitrous oxides present in the air inhaled and inhibits tissue damage and inflammation as well as from four different active ingredients (thymoquinone, carvacrol, tanetol and 4-terpineol) which are capable of neutralizing free radicals.
• Nigella sativa oil may inhibit the inflammation of sinuses and respiratory tracts and prevent microbial infections by means of the ingredients present in its content, thereby alleviating clinical symptoms of upper respiratory tract infections including nasal congestion, head, neck and earache as well as the symptoms of allergic rhinitis.
• Substances are weighed in order to ensure that they are provided in determined amounts for preparing the formulation and mixed at room temperature. Obtained mixture is preserved inside tightly closed and dark-colored bottles below the room temperature (25°C).
• Nasal spray may be administered either by spraying or dropping 1-2 times to each nasal mucosa as frequent as desired within a day.

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• Health & Medical Sciences (AREA)
• Natural Medicines & Medicinal Plants (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
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• General Health & Medical Sciences (AREA)
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• Veterinary Medicine (AREA)
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• Engineering & Computer Science (AREA)
• Biotechnology (AREA)
• Alternative & Traditional Medicine (AREA)
• Mycology (AREA)
• Microbiology (AREA)
• Medical Informatics (AREA)
• Botany (AREA)
• Otolaryngology (AREA)
• Inorganic Chemistry (AREA)
• Organic Chemistry (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• General Chemical & Material Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
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• Medicines Containing Plant Substances (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Medicines Containing Material From Animals Or Micro-Organisms (AREA)
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• 2019
  • 2019-01-03 TR TR2019/00055A patent/TR201900055A2/tr unknown
• 2020
  • 2020-01-01 WO PCT/TR2020/050001 patent/WO2020142054A2/en not_active Ceased

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