US3763861A - Contraceptive means - Google Patents

Contraceptive means Download PDF

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Publication number
US3763861A
US3763861A US00245516A US3763861DA US3763861A US 3763861 A US3763861 A US 3763861A US 00245516 A US00245516 A US 00245516A US 3763861D A US3763861D A US 3763861DA US 3763861 A US3763861 A US 3763861A
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US
United States
Prior art keywords
cap
caps
percent
starch
water
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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.)
Expired - Lifetime
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US00245516A
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English (en)
Inventor
G Gazzani
E Forti
Guercio C Del
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Individual
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Individual
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/02—Contraceptive devices; Pessaries; Applicators therefor for use by males
    • A61F6/04—Condoms, sheaths or the like, e.g. combined with devices protecting against contagion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/08—Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception, e.g. combined with devices protecting against contagion
    • 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
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents

Definitions

  • ABSTRACT Acap device is coated externally and internally with a vaginal mucous membrane antiseptic and is formed of a water-soluble starch.
  • the present invention relates to means applicable by male or female and having a mechanical, antiseptic and orthogenetic protective and preventive action, and to a method of producing such means.
  • means applicable by the male are already known such as e.g. condoms which, however, being a foreign body, have the disadvantage of exerting an irritating and desensibilizing effect and of necessitating subsequent removal.
  • therapeutic medicaments must also often be introduced into the vagina, against which necessity there exist again prejudices and psychic scruples.
  • caps This pharmacological association of spermicidally and germicidally active substances is available in the form of caps, which can be introduced into the vagina either by the male by application to the glans penis, or by the female to the os uteri, prior to sexual intercourse.
  • FIG. 2 is a view of an enlarged section of the cap.
  • C is a cap the starch sheet C, of which contains external layer A on the outer surface thereof and internal layer B on the inner surface thereof.
  • the starch is a water-soluble starch such as described in L. Adam-Cachets Azymes et cachetspackux Paris 1928.
  • the starch dissolves rapidly at the normal temperature of the human body (37C.) and upon contact with the moist vaginal membrane.
  • Approximately 40 percent of the starch of the cap dissolves in water at 37C. in about 5 minutes and about 100 percent so dissolves in about 10 minutes.
  • a cap can have a diameter of approximately 22-24 mm and a weight of about 40 mg.
  • External surface layer A comprises about l824 mg containing 90 percent of Tween 20 (a polyoxyethylene sorbitan monolaurate) and 10-20 percent of active medicinal substances.
  • internal surface layer B comprises about 160-200 mg containing 80-90 percent of a mixture of excipients and about 20-10 percent of active medicinal substances.
  • the ex'cipient mixture contains water-soluble lanolin, talc and Tween 20, in relative weight ratios ranging from about :7024 to 80:60:4, respectively.
  • the active medicinal substances comprise mixtures of phenylmercuric nitrate, benzethonium chloride and methyl p-oxybenzoate, the relative weightratios being in the range of from 2:4:25 and to 325220, respectively.
  • the caps according to this invention are superior to prior caps.
  • the combination of the active substances mentioned above assures optimal medicinal action, while the nature and the proportions of the excipients assure other important advantages.
  • external layer A containing Tween 20 assures three advantages:
  • lntemal layer B containing water-soluble lanolin besides serving as a vehicle for the remaining active substances, also acts as a paste or adhesive, allowing the cap to adhere to the glans penis or the os uteri on which it is applied.
  • caps stability under normal environmental conditions is optimal (after 2 months exposure to normal environment, no alterations were observed). At 60C., stability is still highly satisfactory. It is also good when exposed to a high degree of humidity.
  • the spermicidal activity of the caps has been shown on bulls and men's sperm.
  • the latter test (Bakers test) showed that one-eighth of a cap is sufficient to immobilize 4 ml. of human sperm within 5 minutes.
  • lntravaginal tolerance of the caps has been studied by introducing daily for 20 days a previously determined dose of the product in the vagina of 10 rabbits. No local reactions or irritation were observed macroscopically or microscopically. The tolerance of the caps was demonstrated in a preliminary trial in women by the daily introduction in the vagina of one cap for 20 consecutive days, as illustrated in EXAMPLE 3, below.
  • the active substances, in both layers contain, in turn, a mixture having the following composition (in weight):
  • Phenylmercuric nitrate and benzethonium chloride are known to have bacteriostatic and bactericidal activity.
  • a combination of the two substances is known to be more effective than either alone in arresting the activity of Spirocheta pallida, and is useful for the prevention and local treatment of venereal infection of the female genital organs.
  • EXAMPLE 2 The following tests were conducted in order to indicate the dissolution time of the starch caps such as those illustrated in EXAMPLE 1.
  • a dye Water-soluble Blue Re. Pi. Co.
  • a dye was incorporated in the excipients, which dye had an absorption peak at 637 my At determined intervals the dye concentration was read on a spectrophotometer. In each cap, mg. dye were incorporated. Seven beakers containing exactly 100 ml. water were placed on a thermostatic water bath at 37C. corresponding to body temperature. When the temperature had reached the equilibrium value, seven caps were added successively. The contact time with water was 1 3 5 7 9 and 11 minutes respectively, whereas for the 7th beaker, the complete dissolution of the dye was permitted. This latter test served as a comparison for establishing the percentage values. In order to facilitate a homogeneous dissolution of the dye, the water was stirred slightly during the test with a glass rod.
  • a contraceptive in the form of a shell-shaped cap device adapted to conform to the glans penis or the os uteri, and having elastic consistency and melting properties in the female vagina, said cap having applied on the external surface thereof an external layer (A) functioning to put active substances thereof into immediate contact with mucous membranes of the vagina, and said cap having applied on the interior surface thereof an internal layer (B) functioning to allow the cap to adhere to the glans penis or the os uteri to which it is applied and to carry the remaining active substances, the improvement which comprises said cap device being formed from a cachet-type sheet of starch, about 40 percent of which dissolves in water at 37C. in about 5 minutes, and about 100 percent of which so dissolves in about 10 minutes,
  • a coating defining said external layer (A) on said external surface comprising from about to about percent by weight of polyoxyethylene sorbitan monolaurate, and from about 20 to about 10 percent by weight of a vaginal mucous membrane medicament, coating defining said internal layer on said inner surface comprising from about 80 to about 90 percent by weight of water-soluble lanolin, talc and polyoxyethylene sorbitan monolaurate as an excipient and from about 20 to about 10 percent by weight of the said vaginal mucous membrane antiseptic medicament,

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Reproductive Health (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Urology & Nephrology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Moulds For Moulding Plastics Or The Like (AREA)
  • Moulding By Coating Moulds (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
US00245516A 1968-12-16 1972-04-19 Contraceptive means Expired - Lifetime US3763861A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IT25160/68A IT1037007B (it) 1968-12-16 1968-12-16 Presidio ad uso maschile con funzione meccanica prottiva preven tiva antisettica e o ortogenica nell ambito dei rapporti sessuali e motodo per la sua applicazione

Publications (1)

Publication Number Publication Date
US3763861A true US3763861A (en) 1973-10-09

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ID=11215878

Family Applications (1)

Application Number Title Priority Date Filing Date
US00245516A Expired - Lifetime US3763861A (en) 1968-12-16 1972-04-19 Contraceptive means

Country Status (16)

Country Link
US (1) US3763861A (de)
JP (1) JPS4841634B1 (de)
AT (1) AT300183B (de)
BR (1) BR6914191D0 (de)
CA (1) CA932660A (de)
CH (1) CH517485A (de)
DE (1) DE1960340C3 (de)
DK (1) DK126019B (de)
FR (1) FR2026205B1 (de)
GB (1) GB1286479A (de)
HU (1) HU165420B (de)
IL (1) IL33298A (de)
IT (1) IT1037007B (de)
NL (1) NL160716C (de)
PL (1) PL80355B1 (de)
TR (1) TR18759A (de)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3918443A (en) * 1971-10-20 1975-11-11 Ethyl Corp Method for birth control
US4037601A (en) * 1976-04-30 1977-07-26 Denkinger Marian C Process for preparing sterilized feminine hygiene articles of non-woven and woven textures
US4198976A (en) * 1977-10-11 1980-04-22 The Procter & Gamble Company Vaginal contraceptive
US4265875A (en) * 1976-07-23 1981-05-05 Inveresk Research International Controlled release suppositories
US4381772A (en) * 1980-11-20 1983-05-03 Guistini Fernando G Bioerodible diaphragm
US4647448A (en) * 1984-06-22 1987-03-03 Smith Kline & French Laboratories Limited Pharmaceutical dosage unit
US5819742A (en) * 1996-11-06 1998-10-13 Family Health International Vaginal device for preventing conception or the transmission of sexually transmitted diseases, or both

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS4990541U (de) * 1972-11-29 1974-08-06
JPS5498439U (de) * 1977-12-21 1979-07-11
JPS5533236U (de) * 1978-08-24 1980-03-04
JPS573633U (de) * 1980-06-09 1982-01-09
JPS57129056U (de) * 1981-02-07 1982-08-11
ZA827582B (en) * 1981-11-06 1983-08-31 Ansell Inc Spermicidal condom

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2423475A (en) * 1944-07-27 1947-07-08 Claude W Bice Internal surgical dressing
US2467884A (en) * 1944-02-02 1949-04-19 Nathaniel M Elias Spermicides
US3170464A (en) * 1961-01-26 1965-02-23 Forti Emilio Contraceptive means
US3234091A (en) * 1955-07-08 1966-02-08 Ciba Geigy Corp Shaped medicaments and process for their manufacture
US3342181A (en) * 1963-06-25 1967-09-19 Charles Albert Merminod Forms of ovules
US3443563A (en) * 1966-08-29 1969-05-13 Atsumi Ishihama Vaginal suppository

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2467884A (en) * 1944-02-02 1949-04-19 Nathaniel M Elias Spermicides
US2423475A (en) * 1944-07-27 1947-07-08 Claude W Bice Internal surgical dressing
US3234091A (en) * 1955-07-08 1966-02-08 Ciba Geigy Corp Shaped medicaments and process for their manufacture
US3170464A (en) * 1961-01-26 1965-02-23 Forti Emilio Contraceptive means
US3342181A (en) * 1963-06-25 1967-09-19 Charles Albert Merminod Forms of ovules
US3443563A (en) * 1966-08-29 1969-05-13 Atsumi Ishihama Vaginal suppository

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3918443A (en) * 1971-10-20 1975-11-11 Ethyl Corp Method for birth control
US4037601A (en) * 1976-04-30 1977-07-26 Denkinger Marian C Process for preparing sterilized feminine hygiene articles of non-woven and woven textures
US4265875A (en) * 1976-07-23 1981-05-05 Inveresk Research International Controlled release suppositories
US4292300A (en) * 1976-07-23 1981-09-29 Inveresk Research International Controlled release suppositories
US4198976A (en) * 1977-10-11 1980-04-22 The Procter & Gamble Company Vaginal contraceptive
US4381772A (en) * 1980-11-20 1983-05-03 Guistini Fernando G Bioerodible diaphragm
US4647448A (en) * 1984-06-22 1987-03-03 Smith Kline & French Laboratories Limited Pharmaceutical dosage unit
US5819742A (en) * 1996-11-06 1998-10-13 Family Health International Vaginal device for preventing conception or the transmission of sexually transmitted diseases, or both

Also Published As

Publication number Publication date
NL6917532A (de) 1970-06-18
DE1960340C3 (de) 1975-11-20
GB1286479A (en) 1972-08-23
TR18759A (tr) 1977-08-10
FR2026205B1 (de) 1975-02-21
DE1960340A1 (de) 1970-07-23
BR6914191D0 (pt) 1973-05-08
AT300183B (de) 1972-07-10
IL33298A (en) 1972-12-29
JPS4841634B1 (de) 1973-12-07
CH517485A (fr) 1972-01-15
IL33298A0 (en) 1970-01-29
FR2026205A1 (de) 1970-09-18
DE1960340B2 (de) 1975-04-10
CA932660A (en) 1973-08-28
NL160716C (nl) 1979-12-17
PL80355B1 (de) 1975-08-30
IT1037007B (it) 1979-11-10
DK126019B (da) 1973-06-04
HU165420B (de) 1974-08-28

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