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Nitroxide radioprotector formulations and methods of use

a radioprotector and nitroxide technology, applied in the direction of antinoxious agents, drug compositions, aerosol delivery, etc., can solve the problems of skin complications, many complications, irritation of patients,

Inactive Publication Date: 2009-10-01
MATRIX BIOMED INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0012]In particular embodiments, pharmaceutical compounds described herein can ameliorate conditions caused or enhanced by radiotherapy including skin conditions, mucous membrane conditions, hair follicle conditions, and the like. In specific embodiments the particular skin conditions that the pharmaceutical compositions can treat or prevent include erythema, folliculitis, fibrosis, dry desquamation, moist desquamation, hyperpigmentation, dermatitis, and the like. In some embodiments, pharmaceutical compositions described herein can prevent mucous membrane conditions such as oral mucositis, proctitis, and the like, and are particularly valuable in protecting the rectal mucosa during radiotherapy of tumors in that area, such as prostate tumors. Additionally, in other embodiments the pharmaceutical compositions can treat or prevent hair follicle conditions such as alopecia, and the like.

Problems solved by technology

While the use of radiation therapy is an effective way to treat many kinds of cancer, there are many complications that may result.
These disorders can be very irritating to patients as they both involve pruritus and redness of the skin.
These and other skin complications can arise through oxidative and other stress caused by radiation.
In addition, hair follicles are quite sensitive to radiotherapy.
Losing one's hair can be a source of embarrassment and loss of self esteem.
Symptoms of mucositis vary from pain and discomfort, to an inability to tolerate food or fluids.
Even worse, oral mucositis may be so severe as to limit the patient's ability to tolerate further radiotherapy or chemotherapy.
Patients with damaged oral mucosa and a reduced immunity resulting from radiotherapy are also prone to opportunistic infections in the mouth.
Accordingly, mucositis may also further compromise a patient's response to treatment and / or palliative care.
It is now recognized that these kinds of topical formulations are unsuitable for administration shortly before the actual delivery of radiotherapy to the patient.
Indeed, these product forms leave residues that can result in topical burning, including severe burns, when radiation is administered.

Method used

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  • Nitroxide radioprotector formulations and methods of use
  • Nitroxide radioprotector formulations and methods of use
  • Nitroxide radioprotector formulations and methods of use

Examples

Experimental program
Comparison scheme
Effect test

examples

[0106]The following examples teach methods of making and using nitroxide radioprotector formulations. These examples are illustrative only and are not intended to limit the scope of the teachings herein.

example i

Introduction

[0107]The following study was conducted to evaluate the in vitro percutaneous absorption of Tempol (4-hydroxy Tempo) from four vehicles using excised human skin from elective surgery. This study was conducted using procedures described in the FDA and AAPS Report of the Workshop on Principles and Practices of In Vitro Percutaneous Penetration Studies: Relevance to Bioavailability and Bioequivalence (Pharm. Res. 4:265, 1987), which is hereby incorporated by reference in its entirety.

Methods

[0108]The Tempol formulations used in this in vitro percutaneous absorption study were formulated by Dow Pharmaceutical Sciences, Petaluma, Calif. The composition of these formulations is summarized in Table 1.

TABLE 1Tempol Formulation CompositionReferenceLightly GelledModeratelySprayableEthanolEthanol / Gelled Ethanol / Ethanol / SolutionWaterWaterWaterFormulation ID:IIIIIIIV% by wt.% by wt.% by wt.% by wt.4-Hydroxy776.17tempoEthanol9376.579.533Water015.513.156.87Klucel011.30Laponite XLG0003....

example ii

Introduction

[0115]This study evaluated the effect of multiple applications of a moderately gelled 7% Tempol ethanol / water formulation (Formulation V) on the in vitro percutaneous absorption of Tempol using similar test procedures as employed in Example I. These test procedures were consistent with the FDA and AAPS Report of the Workshop on Principles and Practices of In Vitro Percutaneous Penetration Studies: Relevance to Bioavailability and Bioequivalence (Pharm. Res. 4:265, 1987), which is hereby incorporated by reference in its entirety.

[0116]Test formulations used in this in vitro percutaneous absorption study were prepared by Dow Pharmaceutical Sciences, Petaluma, Calif. Formulation compositions are summarized in Table 4 The viscosity of Formulation V was measured using a Brookfield RVDV-1+viscometer. A sample weighing 8.4134 grams had a measured viscosity of 1215 cps at 22.9° C.

TABLE 4Tempol Formulation CompositionTempolVehicleFormulationFormulationFormulation ID:FormulationFo...

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Abstract

Pharmaceutical compositions useful in preventing and treating negative side effects accompanying radiotherapy are disclosed. More particularly, new formulations that can be applied to the skin and mucous membranes of patients undergoing radiotherapy and methods of using these formulations are disclosed.

Description

RELATED APPLICATIONS[0001]The present application is a continuation of U.S. patent application Ser. No. 10 / 675,225, filed Sep. 29, 2003, which claims priority to U.S. Provisional Application No. 60 / 415,089, filed Oct. 1, 2002, and U.S. Provisional Application No. 60 / 429,887, filed Nov. 26, 2002, both of which are expressly incorporated by reference in their entireties.FIELD OF THE INVENTION[0002]The present invention relates generally to the field of preventing or treating the negative side effects which accompany radiotherapy. More particularly, this invention relates to the discovery of new formulations that can be applied to the skin and mucous membranes of patients undergoing radiotherapy and methods of using these formulations.BACKGROUND OF THE INVENTION[0003]Radiation therapy is an important tool in the fight against cancer and is used in the treatment of as many as 50% of all cancer patients. Accordingly, more than half a million cancer patients receive radiation therapy each...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/445A61P1/00A61KA61K9/12A61K47/10A61K47/38
CPCA61K9/0014A61K9/12A61K47/38A61K47/10A61K31/445A61P1/00A61P17/00A61P17/14A61P39/00
Inventor MAXWELL, KAMERON W.HOYLE, PETER C.
Owner MATRIX BIOMED INC