The present invention relates to a composition comprising at least one GnRH antagonist for use in reducing the risk of recurrent acute urinary retention (AUR) in males of least 45 years of age presenting with a first episode of AUR. Said composition can within four week effectively alleviate urethral obstruction caused by an enlarged prostate, and restore normal urine flow without the need for surgery.
A61K 47/00 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient
A61P 13/00 - Drugs for disorders of the urinary system
A61P 13/08 - Drugs for disorders of the urinary system of the prostate
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
2.
TEVERELIX-TFA IN A DOSAGE REGIME FOR USE IN THE TREATMENT OF PROSTATE CANCER
The present invention relates to a dosage regime for a teverelix-TFA composition used for treating prostate cancer. Said dosage regime comprises a loading dose of 360 mg SC and 180 mg IM, with a low maintenance dose of the teverelix-TFA composition (360 mg SC) every six weeks starting at day 28. Thus, the dosage regime according to the invention provides an improve dosage regimens in which a castration rate of ≥95% is obtained in a treatment period of 52 weeks, and with fewer side effects and adverse events, thereby providing an optimised response/side effect relationship.
The present invention relates to a lyophilization process for preparing a teverelix-TFA lyophilizate, said process comprises the following steps: a) providing a lyophilization suspension by mixing teverelix and trifluoroacetate at a molar ratio sufficient for providing a microcrystalline teverelix-TFA suspension without formation of a gel, and b) lyophilizating the lyophilization suspension, thereby providing a teverelix-TFA lyophilizate. The process provides the possibility of obtaining a “pure” teverelix-TFA lyophilizate i.e. without any undesirable residues in the composition.
F26B 5/06 - Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
A61K 9/19 - Particulate form, e.g. powders lyophilised
The present invention relates to a reconstitutable teverelix-TFA composition having a predefined molar ratio of teverelix to trifluoroacetate which is below the molar ratio required for microcrystal formation. Said composition remains stable during storage e.g., at a temperature around 2-8° C. Upon reconstitution a fixed amount of trifluoroacetate can be added to said composition thereby effectively and simply achieving an exact and desired molar ratio in order to obtain a fluid, milky microcrystalline aqueous teverelix-TFA suspension.
Provided is a teverelix-TFA composition having a molar ratio of teverelix to trifluoroacetate composition of at least 1:2.2. Such a molar ratio will prevent undesirable gel-formation and provide a homogenous suspension, whereby a unique bioavailablity of teverelix is obtained.
The present invention relates to a reconstitutable teverelix-TFA composition having a predefined molar ratio of teverelix to trifluoroacetate which is below the molar ratio required for microcrystal formation. Said composition remains stable during storage e.g. at a temperature around 2-8° C. Upon reconstitution a fixed amount of trifluoroacetate can be added to said composition thereby effectively and simply achieving an exact and desired molar ratio in order to obtain a fluid, milky microcrystalline aqueous teverelix-TFA suspension.
The present invention relates to a lyophilization process for preparing a teverelix-TFA lyophilizate, said process comprises the following steps: a) providing a lyophilization suspension by mixing teverelix and trifluoroacetate at a molar ratio sufficient for providing a microcrystalline teverelix-TFA suspension without formation of a gel, and b) lyophilizating the lyophilization suspension, thereby providing a teverelix-TFA lyophilizate.
The process provides the possibility of obtaining a “pure” teverelix-TFA lyophilizate i.e. without any undesirable residues in the composition.
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
F26B 5/06 - Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
A61K 9/19 - Particulate form, e.g. powders lyophilised
A teverelix-TFA composition having a molar ratio of teverelix to trifluoroacetate composition of at least 1:2.2 is provided. Such a molar ratio will prevent undesirable gel-formation and provide a homogenous suspension, whereby a unique bioavailablity of teverelix is obtained.
The present invention relates to a teverelix-TFA composition having a molar ratio of teverelix to trifluoroacetate composition of at least 1:2.2. Such a molar ratio will prevent undesirable gel-formation and provide a homogenous suspension, whereby a unique bioavailablity of teverelix is obtained.
The present invention relates to a lyophilization process for preparing a teverelix-TFA lyophilizate, said process comprises the following steps: a) providing a lyophilization suspension by mixing teverelix and trifluoroacetate at a molar ratio sufficient for providing an microcrystalline teverelix-TFA suspension without formation of a gel, and b) lyophilizating the lyophilization suspension, thereby providing a teverelix-TFA lyophilizate. The process provides the possibility of obtaining a "pure" teverelix-TFA lyophilizate i.e. without any undesirable residues in the composition.
F26B 5/06 - Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
The present invention relates to a reconstitutable teverelix-TFA composition having a predefined molar ratio of teverelix to trifluoroacetate which is below the molar ratio required for microcrystal formation. Said composition remains stable during storage e.g. at a temperature around 2-8°C. Upon reconstitution a fixed amount of trifluoroacetate can be added to said composition thereby effectively and simply achieving an exact and desired molar ratio in order to obtain a fluid, milky microcrystalline aqueous teverelix-TFA suspension.
A61K 9/19 - Particulate form, e.g. powders lyophilised
A61K 31/185 - AcidsAnhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
F26B 5/06 - Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
The present invention relates to a teverelix-TFA composition having a molar ratio of teverelix to trifluoroacetate composition of at least 1:2.2. Such a molar ratio will prevent undesirable gel-formation and provide a homogenous suspension, whereby a unique bioavailablity of teverelix is obtained.
The present invention relates to a reconstitutable teverelix-TFA composition having a predefined molar ratio of teverelix to trifluoroacetate which is below the molar ratio required for microcrystal formation. Said composition remains stable during storage e.g. at a temperature around 2-8°C. Upon reconstitution a fixed amount of trifluoroacetate can be added to said composition thereby effectively and simply achieving an exact and desired molar ratio in order to obtain a fluid, milky microcrystalline aqueous teverelix-TFA suspension.
F26B 5/06 - Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
15.
A LYOPHILIZATION PROCESS AND A TEVERELIX-TFA LYOPHILIZATE OBTAINED THEREBY
The present invention relates to a lyophilization process for preparing a teverelix-TFA lyophilizate, said process comprises the following steps: a) providing a lyophilization suspension by mixing teverelix and trifluoroacetate at a molar ratio sufficient for providing an microcrystalline teverelix-TFA suspension without formation of a gel, and b) lyophilizating the lyophilization suspension, thereby providing a teverelix-TFA lyophilizate. The process provides the possibility of obtaining a "pure" teverelix-TFA lyophilizate i.e. without any undesirable residues in the composition.
A61K 9/19 - Particulate form, e.g. powders lyophilised
A61K 31/185 - AcidsAnhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
F26B 5/06 - Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
The present invention provides a composition for treating acute urinary retention and reducing the recurrences rates in a male patient by administering a composition for treating acute urinary retention, said composition comprises at least one GnRH antagonist and at least one alpha blocker and/or at least one 5-alpha reductase inhibitor. Said composition provides a rapid reduction in the patient's testosterone level and returns the patient's testosterone level to near baseline in less than eight weeks. Also, the administration of the GnRH antagonist provides a significant reduction in the patient's acute urinary retention symptoms for a medication period of at least four months, six months or more.
The present invention relates to a composition comprising at least one GnRH antagonist and wherein the composition is arranged for being administered in two different administration routes, thereby providing an enhanced bioavailability. Said composition may be used for treating or preventing a disease or condition related to the release of a gonadotropin hormone.
The present invention relates to a composition comprising at least one GnRH antagonist and wherein the composition is arranged for being administered in two different administration routes, thereby providing an enhanced bioavailability. Said composition may be used for treating or preventing a disease or condition related to the release of a gonadotropin hormone.
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