EP4304598A1 - Therapeutic composition for erectile dysfunction treatment - Google Patents

Therapeutic composition for erectile dysfunction treatment

Info

Publication number
EP4304598A1
EP4304598A1 EP21894156.5A EP21894156A EP4304598A1 EP 4304598 A1 EP4304598 A1 EP 4304598A1 EP 21894156 A EP21894156 A EP 21894156A EP 4304598 A1 EP4304598 A1 EP 4304598A1
Authority
EP
European Patent Office
Prior art keywords
tadalafil
sydenafil
citrate
tablet
silicon dioxide
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21894156.5A
Other languages
German (de)
French (fr)
Inventor
Khaled Atma
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP4304598A1 publication Critical patent/EP4304598A1/en
Pending legal-status Critical Current

Links

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence

Definitions

  • Utility model relates to pharmaceutical production and concerns medicines for treatment of erectile dysfunction.
  • Erectile dysfunction is condition during which there is noted complications with causing and/or maintenance of erection, early ejaculation. At this time blood does not normally flow in corpora cavernosa of penis or flown blood is not blocked in corpora cavernosa of penis. The mentioned events condition dissatisfaction of men and their sexual partners in their sexual lives. Erectile dysfunction worldwide is noted by 30-50% of men above 40 years of age.
  • trabecular tissue compresses the veins of corpora cavernosa and this provides maintenance of erection.
  • Inflow of blood in corpora cavernosa and above mentioned events are provided by nitrogen oxide, which mainly is released from postsynaptic parasympatic neurons.
  • Nitrogen oxide stimulates creation of cyclic guanosine monophosphate (GMP) in corpora cavernosa, and from its part it causes relaxation of smooth muscle cells.
  • GMP cyclic guanosine monophosphate
  • PDE5 inhibitors are widely used, such as sildenafil, tadalafil, vardenafil etc.
  • PDE5 inhibitors strengthen influence of nitrogen oxide in corpora cavernosa, and this provides increasing of blood inflow in corpora cavernosa, especially during sexual stimulation.
  • PDE5 inhibitors are characterized by dose-depended frequent side effects, such as vision problems (anomaly perception of colors), headache, face redness, nasal obstructions, dizziness, dyspepsia, diarrhea, rash on skin. There shall be also noted that during their long administration it becomes necessary to subsequently increase the dose and this increases also frequency of side effects.
  • PDE5 inhibitors first of all sildenafil, are characterized by short effect, and therefore it shall be administered for several times daily, and this is not recommended. In contrast to the mentioned, some PDE5
  • SUBSTITUTE SHEET (RULE 26) inhibitors first of all Tadalafil, are characterized by long period of action, although their activation starts quite late after administration, and of course it creates problems for users, especially during spontaneous, unplanned sexual activities.
  • the present utility model provides with therapeutic composition for erectile dysfunction treatment which complies with above mentioned requirements.
  • composition for erectile dysfunction treatment contains sydenafil citrate and tadalafil as active ingredients, and dicalcium phosphate dihydrate, microcrystalline cellulose, starch sodium glycidolate, colloidal silicon dioxide and magnesium stearate - as pharmaceutically acceptable additives, components with the following proportion in wt. %:
  • composition has a tablet form.
  • Tmax Maximal concentration time of sydenafil citrate in the blood plasma
  • T1/2 half -elimination period
  • Tmax of tadalafil is 2.5 hours
  • T1/2 makes up 17 hours.
  • combination of above mentioned two ingredients provides rapid effect (about 15-20 minutes) and its long maintenance for about 24 hours (about 24 hours). Further, combination of two active ingredients reduces frequency of side effects.
  • Combination of two active ingredients in one composition can cause their interaction and also delay of their elimination.
  • Qualitative and quantitative indexes of inactive ingredients existed in the composition offered by utility model provide prevention of interaction of sydenafil citrate and tadalafil and also their unhindered release.
  • the composition contains sydenafil citrate and tadalafil as active ingredients, and dicalcium phosphate dihydrate, microcrystalline cellulose, starch sodium glycidolate, colloidal silicon dioxide and magnesium stearate - as pharmaceutically acceptable additives, components with the following proportion in wt. %:
  • the composition has a tablet form.
  • the tablet contains components with the following proportion in mg: Sydenafil citrate 130
  • Tablet can be prepared in pharmaceutical production by commonly known method, preferentially, by wet granulation.
  • Indication for use of the tablet is erection dysfunction of any etiology.
  • Tablet dosage is V tablet once daily. Tablet is administered 15-20 minutes before sexual act.
  • Efficiency of tablet offered by the utility model was studied on 15 rabbits, which were divided in three equal groups.
  • First group was orally administered 14 of the tablet offered by utility model.
  • the second group was orally administered Viagra (sydenafil) tablet of 25 mg dose.
  • Third group was orally administered Sialis (Tadalafil) tablet of 5 mg dose.
  • IIEF international index of their erection function
  • composition offered by utility model, is effective, safe medication for treatment of erection dysfunction.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Gynecology & Obstetrics (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Composition contains sydenafil citrate and tadalafil as active ingredients, and dicalcium phosphate dihydrate, microcrystalline cellulose, starch sodium glycidolate, colloidal silicon dioxide and magnesium stearate – as pharmaceutically acceptable additives.

Description

THERAPEUTIC COMPOSITION FOR ERECTILE DYSFUNCTION TREATMENT
Utility model relates to pharmaceutical production and concerns medicines for treatment of erectile dysfunction.
Erectile dysfunction is condition during which there is noted complications with causing and/or maintenance of erection, early ejaculation. At this time blood does not normally flow in corpora cavernosa of penis or flown blood is not blocked in corpora cavernosa of penis. The mentioned events condition dissatisfaction of men and their sexual partners in their sexual lives. Erectile dysfunction worldwide is noted by 30-50% of men above 40 years of age.
During normal erection, when blood flows in the corpora cavernosa of penis, trabecular tissue compresses the veins of corpora cavernosa and this provides maintenance of erection. Inflow of blood in corpora cavernosa and above mentioned events are provided by nitrogen oxide, which mainly is released from postsynaptic parasympatic neurons. Nitrogen oxide stimulates creation of cyclic guanosine monophosphate (GMP) in corpora cavernosa, and from its part it causes relaxation of smooth muscle cells.
At present for treatment of erectile dysfunction PDE5 inhibitors are widely used, such as sildenafil, tadalafil, vardenafil etc. PDE5 inhibitors strengthen influence of nitrogen oxide in corpora cavernosa, and this provides increasing of blood inflow in corpora cavernosa, especially during sexual stimulation.
Despite of successful use of PDE5 inhibitors in treatment of erectile dysfunction there are the whole range of problems. First of all, they are characterized by dose-depended frequent side effects, such as vision problems (anomaly perception of colors), headache, face redness, nasal obstructions, dizziness, dyspepsia, diarrhea, rash on skin. There shall be also noted that during their long administration it becomes necessary to subsequently increase the dose and this increases also frequency of side effects. Besides, some PDE5 inhibitors, first of all sildenafil, are characterized by short effect, and therefore it shall be administered for several times daily, and this is not recommended. In contrast to the mentioned, some PDE5
SUBSTITUTE SHEET (RULE 26) inhibitors, first of all Tadalafil, are characterized by long period of action, although their activation starts quite late after administration, and of course it creates problems for users, especially during spontaneous, unplanned sexual activities.
From above mentioned aspects it is still actual to provide with medications for treatment of erectile dysfunction which would be activated rapidly, would have long lasting effect and at the same time would have less side effects.
The present utility model provides with therapeutic composition for erectile dysfunction treatment which complies with above mentioned requirements.
The essence of utility model is that composition for erectile dysfunction treatment contains sydenafil citrate and tadalafil as active ingredients, and dicalcium phosphate dihydrate, microcrystalline cellulose, starch sodium glycidolate, colloidal silicon dioxide and magnesium stearate - as pharmaceutically acceptable additives, components with the following proportion in wt. %:
Sydenafil citrate 20-25
Tadalafil 3-5
Dicalcium phosphate dehydrate 50-60
Microcrystalline cellulose 15-20
Starch soda glycolates 3-5
Colloidal silicon dioxide 1-1.5
Magnesium stearate 1-1.5
In the preferred embodiment of utility model the composition has a tablet form.
In the preferred embodiment of utility model the tablet contains components with the following proportion in mg:
Sydenafil citrate 130
Tadalafil 20
Dicalcium phosphate dehydrate 314
Microcrystalline cellulose 100 Starch soda glycolates 24
Colloidal silicon dioxide 6
Magnesium stearate 6
Maximal concentration time of sydenafil citrate in the blood plasma (Tmax) is 1 hour, and half -elimination period (T1/2) makes up 4 hours. Tmax of tadalafil is 2.5 hours, and T1/2 makes up 17 hours. In composition offered by the utility model, combination of above mentioned two ingredients provides rapid effect (about 15-20 minutes) and its long maintenance for about 24 hours (about 24 hours). Further, combination of two active ingredients reduces frequency of side effects.
Combination of two active ingredients in one composition can cause their interaction and also delay of their elimination. Qualitative and quantitative indexes of inactive ingredients existed in the composition offered by utility model provide prevention of interaction of sydenafil citrate and tadalafil and also their unhindered release.
According to the utility model, the composition contains sydenafil citrate and tadalafil as active ingredients, and dicalcium phosphate dihydrate, microcrystalline cellulose, starch sodium glycidolate, colloidal silicon dioxide and magnesium stearate - as pharmaceutically acceptable additives, components with the following proportion in wt. %:
Sydenafil citrate 20-25
Tadalafil 3-5
Dicalcium phosphate dehydrate 50-60
Microcrystalline cellulose 15-20
Starch soda glycolates 3-5
Colloidal silicon dioxide 1-1.5
Magnesium stearate 1-1.5
In the preferred embodiment of the utility model, the composition has a tablet form.
In the preferred embodiment of the utility model, the tablet contains components with the following proportion in mg: Sydenafil citrate 130
Tadalafil 20
Dicalcium phosphate dehydrate 314
Microcrystalline cellulose 100
Starch soda glycolates 24
Colloidal silicon dioxide 6
Magnesium stearate 6
Tablet can be prepared in pharmaceutical production by commonly known method, preferentially, by wet granulation.
Indication for use of the tablet is erection dysfunction of any etiology.
Tablet dosage is V tablet once daily. Tablet is administered 15-20 minutes before sexual act.
Example:
There were mixed 1.3 kg sydenafil citrate, 200 mg tadalafil, 3.14 dicalcium phosphate dihydrate, 1 kg microcrystalline cellulose and 240 mg starch soda glycolates powders. After well mixing the mixture was poured 140 liters of water and mixed well again. In result the obtained mixture was conducted wet granulation and then drying. After drying obtained granules were mixed with 60 mg colloidal silicon dioxide powder and 60 mg of magnesium stearate powder. Obtained mixture was sorted in 600-600 mg capacities and were tableted by the method of direct pressing. In result there were obtained ten 600 mg tablets.
Efficiency study
Efficiency of tablet offered by the utility model was studied on 15 rabbits, which were divided in three equal groups. First group was orally administered 14 of the tablet offered by utility model. The second group was orally administered Viagra (sydenafil) tablet of 25 mg dose. Third group was orally administered Sialis (Tadalafil) tablet of 5 mg dose.
After administration of medications there were studied time of starting of erection, maximal erection achievement time and erection maintenance time.
Data of experiments are mentioned in the table 1. Table 1
As it is seen from the data given in the table 1, offered medication is obviously more effective as from the standpoint of erection start, so from the standpoint of maximal erection achievement and erection maintenance time.
Efficiency was also studied in 15 volunteer men aged 40-50, who were noted erection dysfunction caused by various reasons. Volunteers were divided into three equal groups. Division was realized so that persons with equal parameters in all groups were equally divided. One group was administering Vi tablet offered by utility model once daily for two weeks, the second group was administering Viagra (Sydenafil) tablet of 100 mg dose once daily for two weeks, and the third group was administering Sialis (tadalafil) tablet of 20 mg dose, once daily for two weeks.
After two weeks the volunteers were questioned and there was defined international index of their erection function (IIEF).
Questioning results are given in the table 2.
Table 2 As it is seen from the data given in the table 2, criteria of estimation of offered medication is significantly higher compared to Viagra and Sialis.
Study of side effects
Side effects were studied in 30 volunteer men aged 30-40. Volunteers were divided into three equal groups. Division was realized so that persons with equal parameters in all groups were equally divided. One group was administering Vi tablet offered by utility model once daily for two weeks, the second group was administering Viagra (Sydenafil) tablet of 100 mg dose once daily for two weeks, and the third group was administering Sialis (tadalafil) tablet of 20 mg dose, once daily for two weeks.
After administration of medications there were studied percentage index of side effects in each group.
Received data are given in the table 3.
Table 3
As it is seen from the data given in the table, offered medication is characterized by too less frequency of side effects than Viagra and Sialis.
Therefore, composition, offered by utility model, is effective, safe medication for treatment of erection dysfunction.

Claims

Claims of utility model ■ Therapeutic composition for erectile dysfunction treatment, which contains sydenafil citrate and tadalafil as active ingredients and pharmaceutical excipients, characterized in that it additionally contains tadalafil as active ingredient, and dicalcium phosphate dihydrate, microcrystalline cellulose, starch soda glycolates, colloidal silicon dioxide and magnesium stearate as pharmaceutical excipient, and contains components with the following proportion in wt. %:
Sydenafil citrate 20-25
Tadalafil 3-5
Dicalcium phosphate dehydrate 50-60
Microcrystalline cellulose 15-20
Starch soda glycolates 3-5
Colloidal silicon dioxide 1-1.5
Magnesium stearate 1-1.5
2. Composition according to claim 1, characterized in that it has a tablet form.
3. Composition according to claim 2, characterized in that said tablet contains components with the following proportion in mg:
Sydenafil citrate 130
Tadalafil 20
Dicalcium phosphate dehydrate 314
Microcrystalline cellulose 100
Starch soda glycolates 24
Colloidal silicon dioxide 6
Magnesium stearate 6
EP21894156.5A 2020-11-19 2021-11-18 Therapeutic composition for erectile dysfunction treatment Pending EP4304598A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GEAU202015494U GEU20212096Y (en) 2020-11-19 2020-11-19 Therapeutic composition for erectile dysfunction treatment
PCT/IB2021/060706 WO2022107042A1 (en) 2020-11-19 2021-11-18 Therapeutic composition for erectile dysfunction treatment

Publications (1)

Publication Number Publication Date
EP4304598A1 true EP4304598A1 (en) 2024-01-17

Family

ID=77908189

Family Applications (1)

Application Number Title Priority Date Filing Date
EP21894156.5A Pending EP4304598A1 (en) 2020-11-19 2021-11-18 Therapeutic composition for erectile dysfunction treatment

Country Status (3)

Country Link
EP (1) EP4304598A1 (en)
GE (1) GEU20212096Y (en)
WO (1) WO2022107042A1 (en)

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101778688B1 (en) * 2016-05-31 2017-09-15 한양대학교 에리카산학협력단 Pharmaceutical combination preparation comprising phosphodiesterase―5 inhibitors

Also Published As

Publication number Publication date
WO2022107042A1 (en) 2022-05-27
GEU20212096Y (en) 2021-09-27

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