US3536809A - Medication method - Google Patents
Medication method Download PDFInfo
- Publication number
- US3536809A US3536809A US799910A US3536809DA US3536809A US 3536809 A US3536809 A US 3536809A US 799910 A US799910 A US 799910A US 3536809D A US3536809D A US 3536809DA US 3536809 A US3536809 A US 3536809A
- Authority
- US
- United States
- Prior art keywords
- medicament
- buccal
- strip
- progesterone
- estrone
- 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.)
- Expired - Lifetime
Links
- 239000003814 drug Substances 0.000 title description 46
- 238000000034 method Methods 0.000 title description 14
- 229940079593 drug Drugs 0.000 title description 10
- RJKFOVLPORLFTN-LEKSSAKUSA-N Progesterone Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H](C(=O)C)[C@@]1(C)CC2 RJKFOVLPORLFTN-LEKSSAKUSA-N 0.000 description 34
- 239000000186 progesterone Substances 0.000 description 17
- 229960003387 progesterone Drugs 0.000 description 17
- DNXHEGUUPJUMQT-UHFFFAOYSA-N (+)-estrone Natural products OC1=CC=C2C3CCC(C)(C(CC4)=O)C4C3CCC2=C1 DNXHEGUUPJUMQT-UHFFFAOYSA-N 0.000 description 12
- DNXHEGUUPJUMQT-CBZIJGRNSA-N Estrone Chemical compound OC1=CC=C2[C@H]3CC[C@](C)(C(CC4)=O)[C@@H]4[C@@H]3CCC2=C1 DNXHEGUUPJUMQT-CBZIJGRNSA-N 0.000 description 12
- 229960003399 estrone Drugs 0.000 description 12
- 239000008280 blood Substances 0.000 description 11
- 210000004369 blood Anatomy 0.000 description 11
- 230000000694 effects Effects 0.000 description 7
- 229940088597 hormone Drugs 0.000 description 7
- 239000005556 hormone Substances 0.000 description 7
- 210000004379 membrane Anatomy 0.000 description 7
- 239000012528 membrane Substances 0.000 description 7
- MUMGGOZAMZWBJJ-DYKIIFRCSA-N Testostosterone Chemical compound O=C1CC[C@]2(C)[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 MUMGGOZAMZWBJJ-DYKIIFRCSA-N 0.000 description 6
- JYGXADMDTFJGBT-VWUMJDOOSA-N hydrocortisone Chemical compound O=C1CC[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 JYGXADMDTFJGBT-VWUMJDOOSA-N 0.000 description 6
- 206010047998 Withdrawal bleed Diseases 0.000 description 5
- 239000004744 fabric Substances 0.000 description 5
- 210000002200 mouth mucosa Anatomy 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- ZESRJSPZRDMNHY-YFWFAHHUSA-N 11-deoxycorticosterone Chemical compound O=C1CC[C@]2(C)[C@H]3CC[C@](C)([C@H](CC4)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 ZESRJSPZRDMNHY-YFWFAHHUSA-N 0.000 description 3
- 230000002745 absorbent Effects 0.000 description 3
- 239000002250 absorbent Substances 0.000 description 3
- 210000005178 buccal mucosa Anatomy 0.000 description 3
- ZESRJSPZRDMNHY-UHFFFAOYSA-N de-oxy corticosterone Natural products O=C1CCC2(C)C3CCC(C)(C(CC4)C(=O)CO)C4C3CCC2=C1 ZESRJSPZRDMNHY-UHFFFAOYSA-N 0.000 description 3
- 229960003654 desoxycortone Drugs 0.000 description 3
- 229940011871 estrogen Drugs 0.000 description 3
- 239000000262 estrogen Substances 0.000 description 3
- 229960000890 hydrocortisone Drugs 0.000 description 3
- 229920001223 polyethylene glycol Polymers 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 229960003604 testosterone Drugs 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000011149 active material Substances 0.000 description 2
- 230000002411 adverse Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 239000006189 buccal tablet Substances 0.000 description 2
- 229940046011 buccal tablet Drugs 0.000 description 2
- 239000000969 carrier Substances 0.000 description 2
- 239000006185 dispersion Substances 0.000 description 2
- -1 for example Substances 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 238000007918 intramuscular administration Methods 0.000 description 2
- 230000005906 menstruation Effects 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 230000000717 retained effect Effects 0.000 description 2
- 241000894007 species Species 0.000 description 2
- 230000009885 systemic effect Effects 0.000 description 2
- 239000003826 tablet Substances 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- BFPYWIDHMRZLRN-UHFFFAOYSA-N 17alpha-ethynyl estradiol Natural products OC1=CC=C2C3CCC(C)(C(CC4)(O)C#C)C4C3CCC2=C1 BFPYWIDHMRZLRN-UHFFFAOYSA-N 0.000 description 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 1
- 108090000317 Chymotrypsin Proteins 0.000 description 1
- 229920000742 Cotton Polymers 0.000 description 1
- 102000007260 Deoxyribonuclease I Human genes 0.000 description 1
- 108010008532 Deoxyribonuclease I Proteins 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- BFPYWIDHMRZLRN-SLHNCBLASA-N Ethinyl estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 BFPYWIDHMRZLRN-SLHNCBLASA-N 0.000 description 1
- 239000004952 Polyamide Substances 0.000 description 1
- 241000220317 Rosa Species 0.000 description 1
- 206010039424 Salivary hypersecretion Diseases 0.000 description 1
- 208000010513 Stupor Diseases 0.000 description 1
- 108090000631 Trypsin Proteins 0.000 description 1
- 102000004142 Trypsin Human genes 0.000 description 1
- 238000007792 addition Methods 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000001476 alcoholic effect Effects 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 230000002921 anti-spasmodic effect Effects 0.000 description 1
- 229940124575 antispasmodic agent Drugs 0.000 description 1
- 239000002830 appetite depressant Substances 0.000 description 1
- 239000012736 aqueous medium Substances 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 description 1
- 229960002376 chymotrypsin Drugs 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 229940035811 conjugated estrogen Drugs 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000006003 cornification Effects 0.000 description 1
- RGLYKWWBQGJZGM-ISLYRVAYSA-N diethylstilbestrol Chemical compound C=1C=C(O)C=CC=1C(/CC)=C(\CC)C1=CC=C(O)C=C1 RGLYKWWBQGJZGM-ISLYRVAYSA-N 0.000 description 1
- 229960000452 diethylstilbestrol Drugs 0.000 description 1
- 229940088598 enzyme Drugs 0.000 description 1
- 230000001076 estrogenic effect Effects 0.000 description 1
- 229960002568 ethinylestradiol Drugs 0.000 description 1
- 238000001704 evaporation Methods 0.000 description 1
- 230000008020 evaporation Effects 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 230000002175 menstrual effect Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 239000004745 nonwoven fabric Substances 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 229920002647 polyamide Polymers 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 208000026451 salivation Diseases 0.000 description 1
- 229940125723 sedative agent Drugs 0.000 description 1
- 239000000932 sedative agent Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 230000002269 spontaneous effect Effects 0.000 description 1
- 229960004533 streptodornase Drugs 0.000 description 1
- 239000006190 sub-lingual tablet Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 230000000451 tissue damage Effects 0.000 description 1
- 231100000827 tissue damage Toxicity 0.000 description 1
- 239000012588 trypsin Substances 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- 239000002759 woven fabric Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
- A61J7/0092—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine for holding medicines in, or fixing medicines on, a tooth, e.g. holder containing medicines fixed on a tooth
Definitions
- a method of administering medication employs a strip covering the medicament which is inserted between the gum and cheek so that absorption of the medicament at a predetermined interval through the buccal mucosa into the bloodstream may take effect, after which the strip is removed and discarded.
- the present invention relates generally to improvements in the administration of medicaments and it relates more particularly to an improved method for introducing a medicament into the blood stream.
- the conventional methods of introducing a medicament into the blood stream are by direct injection and by oral administration, in the latter case the medicament being absorbed through tre membrane which lines the passage of the medicament.
- Many medicaments are completely ineffective or of radically reduced efficacy when orally administered since they either are not absorbed or are adversely affected before entering the blood stream and thus do not possess the desired activity.
- the direct injection of the medicament into the blood stream while assuring no modification of the medicament in administration, is a diflicult, inconvenient and highly uncomfortable procedure and requires a high degree of skill.
- Sublingual tablets and any other form of sublingual administration are subject to the limitations that there are smaller surfaces for the transmission through the mucosal membrane, that in the case of sublingual location a substance there placed causes salivation, and by reason of the additional fluid and the position in the mouth is likely to lead to swallowing of at least a portion of the medicament.
- Buecal tablets are known also but there are important drawbacks accompanying their use and they have enjoyed little success. In some instances larger dosages are required to be inserted in the buccal tablet than are needed in the case of the buccal strip of the present invention. In addition they usually take a great deal of time to deliver the medicament to the buccal surface.
- the buccal tablet also causes pressure between the lip and the gum, which may be uncomfortable and painful. This pressure also may cause the tablet to disintegrate and thus more of the contents arelikely to be swallowed.
- a further object of the present invention is to provide an improved method for the administration of hormones.
- a medication form for introducing a pharmaceutically active material into the blood stream for a predetermined period comprising a film or strip carrying a pharrnaceutically active material releasable therefrom in an aqueous medium for absorption through the oral mucosa buccal tissue.
- the present invention involves the method of introducing a medicament into the blood stream comprising positioning a fibrous absorbent strip carrying a medicament releasable therefrom in overlying contact with the oral mucosa buccal tissue.
- While the present method is employed to great advantage in the administration of hormones, for example, progesterone, estrone, testosterone, cortisol, desoxycorticosterone, it may be employed to advantage with other medicaments, for example, protelytic enzymes such as trypsin, chymotrypsin, strepeokinase, streptodornase, appetite depressants, antispasmodics and sedatives, where rapid entrance to the blood stream is highly desirable.
- hormones for example, progesterone, estrone, testosterone, cortisol, desoxycorticosterone
- other medicaments for example, protelytic enzymes such as trypsin, chymotrypsin, strepeokinase, streptodornase, appetite depressants, antispasmodics and sedatives, where rapid entrance to the blood stream is highly desirable.
- the base of the subject medication form or buccal strip is advantageously an absorbent web such as a strip of woven or non-woven fabric, filter paper or cotton gauze, and is of a dimension which may be comfortably retained between the gum and cheek of the subject and can support in a releasable form a sufficient dosage of the medicament to be administered.
- the buccal strip may be advantageously between one and ten centimeters long, for example five centimeters, and between one-half and three centimeters wide, for example, one centimeter.
- the medicament may be carried by the buccal strip in its pure state or it may be admixed with suitable carriers which facilitate the support of the medicament by the buccal strip and its suitable release to the buccal face.
- suitable carriers are Carbowax, polyvinylpyrrolidone, carboxymethyl cellulose, xgurn arabic and other water soluble or dispersible thickening agents and adhesives.
- Pellon 2100 (100% Polyamide fiber) fabric was immersed in a 20% dispersion of progesterone in a molten mixture of 15% Carbowax 400 and Carbowax 4000 to fully impregnate the fabric. The impregnated fabric was then allowed to cool. Theprogressivelyterone carrying fabric is cut into one by two centimeter strips, each strip containing about 26 milligrams of progesterone.
- the subject In the administration of the progesterone in accordance with the present invention the subject merely places and retains the progesterone carrying buccal strip described above between the confronting faces of the gum and the cheek and in contact with the buccal membrane.
- the buccal strip releases the progesterone which directly enters the blood stream through the buccal membrane.
- the rate of release of the progesterone averaged about 2 mgm. minute and the buccal strip was substantially depleted of medicament in approximately 15 minutes. At the end of such period the strip is removed and discarded.
- Menstruation could be induced in such patients by intramuscular injection of mg. of progesterone. Following intramuscular progesterone, withdrawal bleeding could be demonstrated after four to five days.
- buccal strips of size A" to 1" containing 2 mg. of estrone per strip were administered to patients, one strip per day for 15 days. It was found that approximately 95% of the estrone was removed from the buccal strip in approximately 15 minutes,
- estrone were administered orally to such patients, a dose of at least two to three times this amount would be required. In fact, estrone is almost never administered orally because of its comparative lack of efiectiveness by this route. Instead, orally active estrogen compounds such as ethinylestradiol, diethylstilbestrol or conjugated estrogens from pregnant mares urine are used for oral administration. Estrone can produce typical estrogenic vaginal cornification if administered intramuscularly in dosages of one milligram daily for five days. However, continued intramuscular administration must be avoided since this is painful and may cause tissue damage and narcosis.
- a preferred estrone buccal strip was prepared by impregnating filter paper with an alcoholic solution of estrone. The final concentration of estrone in the dried strip was determined by weight after evaporation of the alcohol to be 2 mg. per square cm. The solution that was used contained 1 gm. dissolved in 250 ml. of 96% alcohol. When strips are made up which are 1 cm. in width they may be cut appropriately to fix the dosage level in each strip.
- the progesterone unit dosage administered in the present manner is advantageously between and 50 milligrams and is administered at intervals between 12 and 72 hours. While the unit administration dosage of a hormone in the present form may be between 0.1 and 100 milligrams, the unit administration dosages of the hormones other than progesterone and their respective interval be- It was found that the buccal strips containing estrone, cortisol, testosterone and desoxycorticosterone were depleted of medicament when in contact with the buccal mucosa to the extent of 95 in about 15 minutes.
- the preparation of the present medication forms employing therapeutic agents other than progesterone may be produced in the above manner, the medicament being applied either from a solution or dispersion thereof in water or an organic solvent which is compatible with the medicament or may be carried in any suitable water dispersible or soluble vehicle.
- the solvent or water is removed in any well known manner which will not adversely affect the medicament such as by freeze drying, or the like.
- the particular medicament and the vehicles employed in connection with it generally determine the release of the medicament and therefore the time of its passage across the buccal mucosa. Generally speaking, it is not wise to provide for too quick a release time. It has been found that a range of release time of from 5 to 20 minutes is optimal. In each case the method of administration employed includes the step for discarding the same after substantial depletion of the medicament therefrom.
- the method of securing the systemic effect of a medicament comprising positioning between the confronting faces of the gum and cheek and in contact with the buccal membrane a flexible absorbent removable and discardable non-ingested fabric, gauze or paper strip, of a dimension which may be comfortably retained between the gum and the cheek and can support in a releasable form from all surfaces to the buccal face a suflicient systemic dosage of the medicament to be administered, impregnated with a medicament releaseable therefrom, admixed in a suitable water-soluble or dispersible impregnant carrier adapted to obtain a predetermined average rate of direct release from the buccal strip through the buccal membrane directly into the blood stream of a preselected species of medicament and to obtain an approximate predetermined time period in which the buccal strip is substantially depleted of said medicament, in overlying contact with the oral mucosa from opposite faces of said strip, then removing and discarding the buccal strip after a predetermined approximate time period for substantial depletion of the preselected species of
- the medicament is a hormone selected from the group consisting of progesterone, estrone, testosterone, cortisol and desoxycorticosterone.
Description
United States Patent 3,536,809 MEDICATION METHOD Norman Applezweig, New York, N.Y., assignor to Alza Corporation, Palo Alto, Calif., a corporation of California No Drawing. Continuation-impart of application Ser. No. 492,301, Oct. 1, 1965. This application Feb. 17, 1969, Ser. No. 799,910
Int. Cl. A61j 7/00; A61k 9/00, 17/00 US. Cl. 42428 4 Claims ABSTRACT OF THE DISCLOSURE A method of administering medication employs a strip covering the medicament which is inserted between the gum and cheek so that absorption of the medicament at a predetermined interval through the buccal mucosa into the bloodstream may take effect, after which the strip is removed and discarded.
The present invention relates generally to improvements in the administration of medicaments and it relates more particularly to an improved method for introducing a medicament into the blood stream. This application is a continuation in part of application Ser. No. 492,301, filed Oct. 1, 1965 now abandoned.
The conventional methods of introducing a medicament into the blood stream are by direct injection and by oral administration, in the latter case the medicament being absorbed through tre membrane which lines the passage of the medicament. Many medicaments are completely ineffective or of radically reduced efficacy when orally administered since they either are not absorbed or are adversely affected before entering the blood stream and thus do not possess the desired activity. On the other hand, the direct injection of the medicament into the blood stream, while assuring no modification of the medicament in administration, is a diflicult, inconvenient and highly uncomfortable procedure and requires a high degree of skill.
Sublingual tablets and any other form of sublingual administration are subject to the limitations that there are smaller surfaces for the transmission through the mucosal membrane, that in the case of sublingual location a substance there placed causes salivation, and by reason of the additional fluid and the position in the mouth is likely to lead to swallowing of at least a portion of the medicament. Buecal tablets are known also but there are important drawbacks accompanying their use and they have enjoyed little success. In some instances larger dosages are required to be inserted in the buccal tablet than are needed in the case of the buccal strip of the present invention. In addition they usually take a great deal of time to deliver the medicament to the buccal surface. The buccal tablet also causes pressure between the lip and the gum, which may be uncomfortable and painful. This pressure also may cause the tablet to disintegrate and thus more of the contents arelikely to be swallowed.
It is therefore a principal object of the present invention to provide an improved method for the introduction of medication into the blood stream.
A further object of the present invention is to provide an improved method for the administration of hormones.
The above and other objects of the present invention will become apparent from a reading of the following description in which examples are given merely by way of illustration and are not intended to limit the scope of the invention.
It has been found that certain medicaments when slowly released to the oral mucosa and particularly to the buccal membrane are absorbed thereby and efficiently enter the blood stream and unexpectedly effect a highly superior therapy or activity. Thus, in a sense of the present invention contemplates the employment of a medication form for introducing a pharmaceutically active material into the blood stream for a predetermined period comprising a film or strip carrying a pharrnaceutically active material releasable therefrom in an aqueous medium for absorption through the oral mucosa buccal tissue. In another sense the present invention involves the method of introducing a medicament into the blood stream comprising positioning a fibrous absorbent strip carrying a medicament releasable therefrom in overlying contact with the oral mucosa buccal tissue.
While the present method is employed to great advantage in the administration of hormones, for example, progesterone, estrone, testosterone, cortisol, desoxycorticosterone, it may be employed to advantage with other medicaments, for example, protelytic enzymes such as trypsin, chymotrypsin, strepeokinase, streptodornase, appetite depressants, antispasmodics and sedatives, where rapid entrance to the blood stream is highly desirable.
The base of the subject medication form or buccal strip is advantageously an absorbent web such as a strip of woven or non-woven fabric, filter paper or cotton gauze, and is of a dimension which may be comfortably retained between the gum and cheek of the subject and can support in a releasable form a sufficient dosage of the medicament to be administered. The buccal strip may be advantageously between one and ten centimeters long, for example five centimeters, and between one-half and three centimeters wide, for example, one centimeter.
The medicament may be carried by the buccal strip in its pure state or it may be admixed with suitable carriers which facilitate the support of the medicament by the buccal strip and its suitable release to the buccal face. Examples of such carriers are Carbowax, polyvinylpyrrolidone, carboxymethyl cellulose, xgurn arabic and other water soluble or dispersible thickening agents and adhesives.
As an example of a medication form, its preparation and use in accordance with the present invention, a piece of Pellon 2100 (100% Polyamide fiber) fabric was immersed in a 20% dispersion of progesterone in a molten mixture of 15% Carbowax 400 and Carbowax 4000 to fully impregnate the fabric. The impregnated fabric was then allowed to cool. The progresterone carrying fabric is cut into one by two centimeter strips, each strip containing about 26 milligrams of progesterone.
In the administration of the progesterone in accordance with the present invention the subject merely places and retains the progesterone carrying buccal strip described above between the confronting faces of the gum and the cheek and in contact with the buccal membrane. The buccal strip releases the progesterone which directly enters the blood stream through the buccal membrane. The rate of release of the progesterone averaged about 2 mgm. minute and the buccal strip was substantially depleted of medicament in approximately 15 minutes. At the end of such period the strip is removed and discarded.
Subjectswho were administered progesterone in dosages of 26 mg. at intervals of 24 hours for five days by the use of the buccal strip medication form in the manner set forth above had withdrawal bleeding two to five days following cessation of medication.
These were patients who suffered from a variety of menstrual difiiculties and were not capable of spontaneous menstruation. Menstruation could be induced in such patients by intramuscular injection of mg. of progesterone. Following intramuscular progesterone, withdrawal bleeding could be demonstrated after four to five days.
Repeated use of buccal progesterone at intervals of one month, and even at shorter intervals, consistently induced withdrawal bleeding.
In contrast, subjects administered progesterone orally in the same dosages and at the same intervals as above failed to show any withdrawal bleeding. The literature reports that, on occasion, withdrawal bleeding has been induced in patients following oral administration of dosages of 500 mg. to 1500 mg. of progesterone. Such an effect cannot be obtained consistently however.
In another series of trials, buccal strips of size A" to 1" containing 2 mg. of estrone per strip were administered to patients, one strip per day for 15 days. It was found that approximately 95% of the estrone was removed from the buccal strip in approximately 15 minutes,
so that the rate of release of the estrone averaged about .133 mg. per minute. These patients were all either prepuberal or postmenopausal. In each case vaginal cystology showed castrate cells. After as little as four days, the vaginal cells showed 2 to 3+ estrogen effect, and after eleven days, a full 4+ estrogen effect. If estrone were administered orally to such patients, a dose of at least two to three times this amount would be required. In fact, estrone is almost never administered orally because of its comparative lack of efiectiveness by this route. Instead, orally active estrogen compounds such as ethinylestradiol, diethylstilbestrol or conjugated estrogens from pregnant mares urine are used for oral administration. Estrone can produce typical estrogenic vaginal cornification if administered intramuscularly in dosages of one milligram daily for five days. However, continued intramuscular administration must be avoided since this is painful and may cause tissue damage and narcosis.
A preferred estrone buccal strip was prepared by impregnating filter paper with an alcoholic solution of estrone. The final concentration of estrone in the dried strip was determined by weight after evaporation of the alcohol to be 2 mg. per square cm. The solution that was used contained 1 gm. dissolved in 250 ml. of 96% alcohol. When strips are made up which are 1 cm. in width they may be cut appropriately to fix the dosage level in each strip.
The progesterone unit dosage administered in the present manner is advantageously between and 50 milligrams and is administered at intervals between 12 and 72 hours. While the unit administration dosage of a hormone in the present form may be between 0.1 and 100 milligrams, the unit administration dosages of the hormones other than progesterone and their respective interval be- It was found that the buccal strips containing estrone, cortisol, testosterone and desoxycorticosterone were depleted of medicament when in contact with the buccal mucosa to the extent of 95 in about 15 minutes.
The preparation of the present medication forms employing therapeutic agents other than progesterone may be produced in the above manner, the medicament being applied either from a solution or dispersion thereof in water or an organic solvent which is compatible with the medicament or may be carried in any suitable water dispersible or soluble vehicle. The solvent or water is removed in any well known manner which will not adversely affect the medicament such as by freeze drying, or the like.
The particular medicament and the vehicles employed in connection with it generally determine the release of the medicament and therefore the time of its passage across the buccal mucosa. Generally speaking, it is not wise to provide for too quick a release time. It has been found that a range of release time of from 5 to 20 minutes is optimal. In each case the method of administration employed includes the step for discarding the same after substantial depletion of the medicament therefrom.
While there has been described a preferred embodiment of the present invention, it is apparent that numerous alterations, omissions and additions may be made without departing from the spirit thereof.
What is claimed is:
1. The method of securing the systemic effect of a medicament comprising positioning between the confronting faces of the gum and cheek and in contact with the buccal membrane a flexible absorbent removable and discardable non-ingested fabric, gauze or paper strip, of a dimension which may be comfortably retained between the gum and the cheek and can support in a releasable form from all surfaces to the buccal face a suflicient systemic dosage of the medicament to be administered, impregnated with a medicament releaseable therefrom, admixed in a suitable water-soluble or dispersible impregnant carrier adapted to obtain a predetermined average rate of direct release from the buccal strip through the buccal membrane directly into the blood stream of a preselected species of medicament and to obtain an approximate predetermined time period in which the buccal strip is substantially depleted of said medicament, in overlying contact with the oral mucosa from opposite faces of said strip, then removing and discarding the buccal strip after a predetermined approximate time period for substantial depletion of the preselected species of medicament.
2. The method of claim 1 in which the medicament is a hormone.
3. The method of claim 1 in which the medicament is a hormone selected from the group consisting of progesterone, estrone, testosterone, cortisol and desoxycorticosterone.
4. The method of claim 2 in which the strip contains from 0.1 mg. to mg. of said hormone.
References Cited UNITED STATES PATENTS 3,339,546 9/ 1967 Chen 424-28 XR 3,429,308 2/1969 Russell 1281 SHEP K. ROSE, Primary Examiner US. Cl. X.R.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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US79991069A | 1969-02-17 | 1969-02-17 |
Publications (1)
Publication Number | Publication Date |
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US3536809A true US3536809A (en) | 1970-10-27 |
Family
ID=25177075
Family Applications (1)
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US799910A Expired - Lifetime US3536809A (en) | 1969-02-17 | 1969-02-17 | Medication method |
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