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 The leading web portal for pharmacy resources, news, education and careers March 24, 2017
Pharmacy Choice - Pharmaceutical News - Patent Issued for Pharmaceutical Compositions Comprising Plant Extracts and Methods for Reducing Duration of a Common Cold Using Same (USPTO 9555069) - March 24, 2017

Pharmacy News Article

 2/17/17 - Patent Issued for Pharmaceutical Compositions Comprising Plant Extracts and Methods for Reducing Duration of a Common Cold Using Same (USPTO 9555069)

By a News Reporter-Staff News Editor at Drug Week A patent by the inventors Clarot, Timothy L. (Phoenix, AZ); Ascarate, Arlene M. (Gilbert, AZ), filed on April 29, 2015, was published online on January 31, 2017, according to news reporting originating from Alexandria, Virginia, by NewsRx correspondents (see also MATRIXX INITIATIVES, INC.).

Patent number 9555069 is assigned to MATRIXX INITIATIVES, INC. (Scottsdale, AZ).

The following quote was obtained by the news editors from the background information supplied by the inventors: "The common cold is one of the most widespread viral diseases infecting mankind. It is universal and frequently contracted, infecting children and adults throughout their lives, and is one of the most common causes of doctor visits and absenteeism from school and work. The common cold is responsible for more widespread economic loss than perhaps most other medical conditions as measured by direct costs of $17 billion per year and indirect costs of $22.5 billion per year in the U.S. alone, (see A. Fendrick, et al., 'The Economic Burden of Non-Influenza-Related Viral Respiratory Tract Infection in the United States,' Arch. Intern. Med., 163(4), 487-494, 2003).

"Currently there is no universally accepted, proven medical intervention that is widely available for treatment of the common cold. Most consumers use over-the-counter medications that reduce the inflammation associated with viral infections, in order to reduce the severity of their symptoms. These over-the-counter medications include analgesics, decongestants, mucolytics, and antihistamines, all of which reduce specific mediators of inflammation associated with colds symptoms. A product that is effective in the treatment of the common cold could markedly reduce the negative impact and economic losses otherwise incurred. A greater clinical benefit may be possible by interrupting the viral infection at more proximate points in the infection thereby mitigating the process and avoiding its evolution.

"Rhinovirus infection is the most common cause of the common cold, (see R. Dolin, 'Common Viral Respiratory Infections and Severe Acute Repiratory Syndrome (SARS)' in A. e. Fauci, Harrison's Principles of Internal Medicine, pp. 1120-1126, New York: McGraw Hill, 2008). The virus is typically introduced into the nasal passage where it quickly infects cells in the nasal mucosa, reproduces, then spreads to other epithelial cells through ciliary transport of new virions shed into the lumen. This process of viral replication and spread takes place within the first 8-24 hours, at which point symptoms of the colds illness begin to manifest, (see M. Terajima, 'Rhinovirus Infection of Primary Cultures of Human Tracheal Epithelium: Role of ICAM-1 and IL-1.beta.,' Am J PhysiolLung Physiol. 273 (4), L749-L759, 1997). Therefore, it is important to clinically intervene in the colds illness within the first 8-24 hours following infection.

"Most researchers believe that intervening very early in the course of viral illness with compounds that interfere with viral replication, virus spead and infection provide the best chance of reducing its overall symptom burden. Few drugs have proven to work in relieving the common cold by interfering with the process of viral infection.

"Therefore, new products usable during the manifestation of the colds illness are needed. For example, new pharmaceutical compositions usable for early intervention and reduction of duration of common colds are desirable."

In addition to the background information obtained for this patent, NewsRx journalists also obtained the inventors' summary information for this patent: "Various embodiments of the present disclosure provide compositions and methods for reducing duration of common colds in humans and for reducing severity or duration of common cold symptoms such as nasal congestion, runny nose, watery eyes, dry/scratchy throat and sneezing.

"In various embodiments, compositions that reduce duration of a common cold in a human expressing symptoms characteristic of the common cold, and that reduce severity or duration of common cold symptoms such as nasal congestion, runny nose, watery eyes, dry/scratchy throat and sneezing, comprise an extract of Luffa Operculata (L. operculata), S. officinale (V. sabadilla), and/or Galphimia Glauca (G. glauca) in a pharmaceutically acceptable carrier. In various embodiments, such compositions further comprise at least one drug active.

"In various embodiments, compositions that reduce duration of a common cold in a human expressing symptoms characteristic of the common cold, and that reduce severity or duration of common cold symptoms such as nasal congestion, runny nose, watery eyes, dry/scratchy throat and sneezing, comprise extracts of Luffa Operculata (L. operculata), S. officinale (V. sabadilla), and Galphimia Glauca (G. glauca) in a pharmaceutically acceptable carrier. In various embodiments, such compositions further comprise at least one drug active.

"In various embodiments, compositions useful for reducing duration of a common cold in a human expressing symptoms characteristic of the common cold, and for reducing severity or duration of common cold symptoms such as nasal congestion, runny nose, watery eyes, dry/scratchy throat and sneezing, are formulated into physical forms amenable to administration to the nasal mucosa of the subject in need of treatment. In various embodiments, administration of such compositions comprises applying a therapeutically effective amount of the composition into one or both nostrils of the human in need of treatment.

"In various embodiments, compositions in accordance with the present disclosure, useful for reducing duration of common colds in humans and for reducing severity or duration of common cold symptoms such as nasal congestion, runny nose, watery eyes, dry/scratchy throat and sneezing, comprise: (a) at least one or any combination of L. operculata 10 wt. % extract (MT) at of about 0.001 wt. % to about 0.1 wt. %; S. officinale 3.times. extract at about 0.001 wt. % to about 0.1 wt. %; and G. glauca 10 wt. % extract (MT) at about 0.001 wt. % to about 0.1 wt. %; and (b) a pharmaceutically acceptable carrier.

"In various embodiments, compositions in accordance with the present disclosure, useful for reducing duration of common colds in humans and for reducing severity or duration of common cold symptoms such as nasal congestion, runny nose, watery eyes, dry/scratchy throat and sneezing, comprise: (a) at least one or any combination of: L. operculata 10 wt. % extract (MT) at of about 0.001 wt. % to about 0.1 wt. %, S. officinale 3.times. extract at about 0.001 wt. % to about 0.1 wt. %, and G. glauca 10 wt. % extract (MT) at about 0.001 wt. % to about 0.1 wt. %; (b) a thickener at about 0.001 wt. % to about 10 wt. %; a surfactant at about 0.001 wt. % to about 10 wt. %; (d) an organic acid at about 0.01 wt. % to about 10 wt. %; (e) at least one of a carbonate, sulfate, and phosphate totaling about 0.01 wt. % to about 10 wt. %; (f) at least one inhalant at about 0.001 wt. % to about 1 wt. %; (g) optionally at least one amino acid at about 0.01 wt. % to about 10 wt. %; (h) optionally at least one salt at about 0.01 wt. % to about 1 wt. %; (i) optionally at least one fragrance at about 0.001 wt. % to about 1 wt. %; (j) optionally at least one sweetener at about 0.001 wt. % to about 1 wt. %; (k) optionally at least one of a preservative, ultraviolet inhibitor and antioxidant at about 0.001 wt. % to about 1 wt. %; (l) optionally a non-aqueous solvent or vehicle at about 0.001 wt. % to about 99 wt. %; and (m) remainder water, wherein each wt. % is based on the total weight of the composition.

"In various embodiments, a method for reducing duration of a common cold comprises applying daily to the nasal passageways of a human in need of treatment a therapeutically effective amount of a composition comprising extracts of L. operculata, S. officinale and G. glauca in a pharmaceutically acceptable carrier. In various embodiments, the pharmaceutically acceptable carrier is predominately water. In various embodiments, the composition further comprises any combination of thickener, surfactant, acid, alkaline material, inhalant, amino acid, salt, drug active, fragrance, sweetener, and/or preservative.

"In various embodiments, a method for reducing the severity or duration of common cold symptoms in humans, which includes reducing severity or duration of any one of nasal congestion, runny nose, watery eyes, dry/scratchy throat and sneezing, comprises nasal administration of a therapeutically effective amount of a pharmaceutical composition comprising extracts of L. operculata, S. officinale and G. glauca in a pharmaceutically acceptable carrier. In various embodiments, the pharmaceutically acceptable carrier is predominately water. In various embodiments, the composition further comprises any combination of thickener, surfactant, acid, alkaline material, inhalant, amino acid, salt, drug active, fragrance, sweetener, and/or preservative.

"In various embodiments, a method for reducing the intensity or bothersomeness of a common cold comprises nasal administration of a therapeutically effective amount of a pharmaceutical composition comprising extracts of L. operculata, S. officinale and G. glauca in a pharmaceutically acceptable carrier. In various embodiments, the pharmaceutically acceptable carrier is predominately water. In various embodiments, the composition further comprises any combination of thickener, surfactant, acid, alkaline material, inhalant, amino acid, salt, drug active, fragrance, sweetener, and/or preservative.

"In various embodiments, a method for reducing duration of a common cold in a human comprises nasal administration of a therapeutically effective amount of a pharmaceutical composition consisting essentially of: (a) from about 0.001 wt. % to about 0.5 wt. % of a mixture of L. operculata 10 wt. % extract (MT), S. officinale 3.times. extract and G. glauca 10 wt. % extract (MT); (b) from about 0.5 wt. % to about 1.5 wt. % of a cellulosic thickener; from about 0.01 wt. % to about 1 wt. % of a surfactant; (d) from about 0.1 wt. % to about 1 wt. % of an organic acid; (e) from about 0.1 to about 2 wt. % of a mixture of sodium monobasic and sodium dibasic phosphate salts; (f) from about 0.1 wt. % to about 1 wt. % of a mixture of menthol, eucalyptol and eugenol; (g) from about 0.05 wt. % to about 0.5 wt. % of an amino acid; (h) from about 0.1 wt. % to about 1 wt. % sodium chloride; and (i) from about 90 wt. % to about 99 wt. % water, wherein each wt. % is based on the total weight of the composition.

"In various embodiments, a method for reducing the severity or duration of common cold symptoms in humans, which includes reducing severity or duration of any one of nasal congestion, runny nose, watery eyes, dry/scratchy throat and sneezing, comprises nasal administration of a therapeutically effective amount of a pharmaceutical composition consisting essentially of: (a) from about 0.001 wt. % to about 0.5 wt. % of a mixture of L. operculata 10 wt. % extract (MT), S. officinale 3.times. extract and G. glauca 10 wt. % extract (MT); (b) from about 0.5 wt. % to about 1.5 wt. % of a cellulosic thickener; from about 0.01 wt. % to about 1 wt. % of a surfactant; (d) from about 0.1 wt. % to about 1 wt. % of an organic acid; (e) from about 0.1 to about 2 wt. % of a mixture of sodium monobasic and sodium dibasic phosphate salts; (f) from about 0.1 wt. % to about 1 wt. % of a mixture of menthol, eucalyptol and eugenol; (g) from about 0.05 wt. % to about 0.5 wt. % of an amino acid; (h) from about 0.1 wt. % to about 1 wt. % sodium chloride; and (i) from about 90 wt. % to about 99 wt. % water, wherein each wt. % is based on the total weight of the composition.

"In various embodiments, a method for reducing intensity or bothersomeness of a common cold in a human comprises nasal administration of a therapeutically effective amount of a pharmaceutical composition consisting essentially of: (a) from about 0.001 wt. % to about 0.5 wt. % of a mixture of L. operculata 10 wt. % extract (MT), S. officinale 3.times. extract and G. glauca 10 wt. % extract (MT); (b) from about 0.5 wt. % to about 1.5 wt. % of a cellulosic thickener; from about 0.01 wt. % to about 1 wt. % of a surfactant; (d) from about 0.1 wt. % to about 1 wt. % of an organic acid; (e) from about 0.1 to about 2 wt. % of a mixture of sodium monobasic and sodium dibasic phosphate salts; (f) from about 0.1 wt. % to about 1 wt. % of a mixture of menthol, eucalyptol and eugenol; (g) from about 0.05 wt. % to about 0.5 wt. % of an amino acid; (h) from about 0.1 wt. % to about 1 wt. % sodium chloride; and (i) from about 90 wt. % to about 99 wt. % water, wherein each wt. % is based on the total weight of the composition."

URL and more information on this patent, see: Clarot, Timothy L.; Ascarate, Arlene M.. Pharmaceutical Compositions Comprising Plant Extracts and Methods for Reducing Duration of a Common Cold Using Same. U.S. Patent Number 9555069, filed April 29, 2015, and published online on January 31, 2017. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9555069.PN.&OS=PN/9555069RS=PN/9555069

Keywords for this news article include: Antipruritic, Anions, Peptides, Proteins, Chemicals, Phosphates, Rhinovirus, Amino Acids, Common Cold, RNA Viruses, Menthol Therapy, Sodium Chloride, Phosphoric Acids, Respiratory Agents, Drugs and Therapies, RNA Virus Infections, MATRIXX INITIATIVES INC., Picornaviridae Infections, Nasal Lubricants and Irrigations.

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