US 3418999 A
Description (OCR text may contain errors)
Dec. 31, 1968 D. w. DAVIS 3,418,999
METHOD OF SWALLOWING A PILL Filed Feb. 12, 1964 Sheet of 2 3M Z0, IEWNVENTOR Dec. 31, 1968 Filed Feb. 12, 1964 DENSITY D. w. DAVIS 3,418,999
METHOD OF SWALLOWING A PILL Sheet 2 of 2 0.2 0.4- 0.6 0.8 L0 1.2 1.4 Lb 1.8
United States Patent 3,418,999 METHOD OF SWALLOWIN G A PILL Donald W. Davis, 7038 N. Beach Drive, Milwaukee, Wis. 53217 Filed Feb. 12, 1964, Ser. No. 344,413 3 Claims. (Cl. 128-1) ABSTRACT OF THE DISCLOSURE The invention relates to overcoming the difliculty experienced by some persons of gagging or choking while swallowing medicinal pills. This difficulty is overcome by providing pills having a density of less than 1.0 so that such pill will tend to float on water. In swallowing such pill the person takes a single swallowable amount of water in the mouth together with such pill, keeping the lips closed, then bows the head downwardly and forwardly while keeping the water and pill in the mouth, and then easily swallows same while the head is held in such downwardly bowed position without experiencing gagging or choking.
This invention relates to solid discrete medicinals, in any form, such as capsules, pills, tablets, troches, lozenges and pellets, for oral administration for any purpose, of any predetermined density in relation to size, to facilitate easy swallowing with water when the head is held in a bowed position.
Swallowing a pill, or other form of solid medicine, would seem to be such a basically simple procedure for those who make a practice of swallowing food, that the matter seldom comes up for consideration. In case a patient is puzzled or apprehensive about the matter, a doctor is likely to give some such advice as Just place the pill on the back part of the tongue then take some water in the mouth, tip the head back, and SWAL- LOW! A fortunate percentage of the time this procedure produces the desired result: the pill is washed down the esophagus and into the stomach.
It is commonly recognized, however, that due to various vitiating circumstances, this ideal result is not invariably achieved. In getting the water into the mouth, the pill may be dislodged from its strategic location on the tongue. The playful tongue may disobey orders and manipulate the pill into a safer corner, where gagging is not threatened. A bibulous pill may stick to the tongue and fail to be caught up in the stream of the swallow. Initiation of movement of the pill may occur late in the flow of the swallow, and fail to clear the throat or esophagus before the water is gone. Pill swallowing patients will eventually experience the discomfort of a pill stuck in the esophagus, and the need to drink repeatedly to dislodge it. When a pill requires a second try, the time delay is such that it may begin to disintegrate in the mouth from the action of the water. This can be most unpleasant, depending upon the nature of the preparation. There appears to be ample evidence that difliculty in swallowing any form of solid medicinals is experienced in greater or lesser degree by a great many people. Although with some patients the problem may be psychological, there appears to be good physical reasons why entirely normal patients might also be expected to have difficulty in swallowing some solid preparations.
Examination of a variety of pills, tablets, capsules, etc., prepared and offered for oral administration, has shown that these solid preparations vary widely in density. Compressed tablets tend to be high in density. Gelatin capsules tend to be low in density since they usually contain loose powders. Experimentation with pills, tablets, etc. of varying density has shown that extremely heavy pills are unpleasant to swallow, especially when of large size, because of the gagging sensation produced when the large, heavy pill contacts the back of the mouth and throat. With very low density pills, especially capsules, which readily float on the water taken into the mouth, swallowing failure may occur by the usual head tipped back method of swallowing, because the pill floats toward the trailing end of the swallow of water, away from the throat. The water then goes down alone, and the capsule is left in the mouth, or more uncomfortably, in the throat.
I have discovered that it is possible to avoid all of these swallowing difliculties by adjusting the density of the pill, capsule, etc., to a critical value in relation to its volume, so that it exhibits a controlled degree of buoyancy when immersed in water. In .conjunction with this adjusted density, the patient must use a new and novel technique for swallowing. The pill is taken into the mouth with a generous swallow of water, then instead of tipping the head back, it is tipped down and forward, as in how ing. The swallow is initiated and completed while the head is in the bowed position. With the head in this position, the capsule, pill, etc., floating at the surface of the swallow of water is near and approaching the throat as preparation is made for swallowing. Since the pill is buoyed up and supported by the water, there is very little mouth or throat contact, hence it produces little or no sensation from its presence. The tongue is helpless to move or control the position of the pill. With the weight load of water and pill on the forward part of the month, away from the throat, there is no gagging sensation. The mouth contents feel stable and comfortable. There is no critical timing of the swallowing factors about which the patient must be concerned. The swallow is easily initiated whenever the patient is ready. The floating pill is in mobile condition, and is infallibly projected into the throat by the swallowing action.
As the swallow starts, the throat opens, and the pill is in position to pass through immediately, while the throat is dilated to its maximum. The whole swallow of water is now behind the pill, in proper position to propel it through the esophagus and into the stomach. I find that with a generous swallow of water, even fairly large pills, having suitable buoyancy, can be swallowed by this bowed head method with no discomfort or apprehension, in fact, with very little sensation.
Further details and advantages of my invention will be apparent from the following specification and accompanying drawings, wherein FIGURE 1 is a diagrammatic view of a persons head in the process of swallowing a pill with water,
FIGURE 2 is a similar view showing a person swallowing a pill according to the present invention, and
FIGURE 3 is a graph showing the relation of volume to density of pills and tablets.
Referring to the drawings, FIGURE 1 is a cross-sectional diagram of the head of a person in the act of swallowing water with a floating type pill in the mouth when the head is tipped back as in the conventional method of swallowing. The pill 4 floating at the surface of the swallow of water 3 is near the front of the month away from the throat. When the swallow is initiated, the movement of the tongue may trap the pill in the roof of the month. In any case, the swallow of water is the wrong position to propel the pill into the throat. Then tendency of low density pills or capsules to cause swallowing difficulty with the head tipped back is therefore explained.
FIGURE 2 shows how a pill is swallowed with water according to the present invention. A swallow of water 5 with a floating type pill 6 is in the mouth and the head is tipped forward in a bowed position. The pill floating at the surface of the water is near the throat, at the leading portion of the swallow, where the whole swallow of water is effective in carrying it through the esophagus into the stomach.
It is to be noted that the technique of drinking with the head in a lowered position follows the procedure used by animals, as well as by primitive man, in drinking from ponds, streams, etc. Drinking with the head in an upright position is a learned practice of civilized man. It carries with it the danger that liquid, or more unfortunately, solid matter, may enter the trachea, largely through the action of gravity, in case of faulty protective action of the epiglottis during the act of swallowing. The bowed head method of swallowing solid medicinals is therefore free of any danger of choking due to entrance of foreign matter into the trachea.
Experiments were conducted using several observers who made test swallowings of gelatin capsules of various sizes which had been adjusted to selected densities by filling with calculated amounts of granuated sugar, Only the density range less than 1.0 was investigated, which represents the type of capsules which will float on water. All capsules were swallowed by the bowed head method. Observers reported the amount and type of mouth and throat sensation experienced with the various density capsules of various sizes.
It was observed that at the lower capsule densities, particularly with the larger capsules, the amount of mouth sensation increases. At some low density the degree of sensation becomes objectionable, due to the pressure of the capsule against the throat, and the resulting gagging sensation. This effect is undoubtedly due to the excessive buoyancy of very low density capsules, which makes them float partially above the surface of the swallow of water, and press against the tissues of the mouth or throat. This means that for any given size of capsule there is an optimum density range which will give suflicient buoyancy to give positive floating on the swallow of water in the mouth, but not excessive buoyancy which will give rise to mouth sensation.
I have determined the degree of mouth sensation obtained with capsules ranging in size from No. 4 (about 0.2 cc.) to No. 000 (about 1.8 cc.) and having densities ranging from 0.2 to nearly 1.0. Degree of mouth sensation has been characterized in three categories as no sensation, sensation not objectionable, and sensation objectionable. These data are shown graphically in FIG- URE 3. Curve 10 represents the approximate minimum density having no mouth sensation, curve represents the approximate minimum density having noticeable, but not very objectionable mouth sensation, and curve represents the density at, and below which, mouth sensation is very noticeable, and may be objectionable.
This graph shows that as the volume of the capsule increases, the density must increase, approaching 1.0, in order to avoid the excessive buoyancy which gives objectionable mouth sensation. The small capsules are much less critical as regards acceptable density for minimum sensation, than the large capsule. This is an understandable relationship, because of the smaller amount of sensation possible from the surface pressure from a small capsule.
From observing the rate of rise of various size and density capsules when immersed in water, I have concluded that a rate of rise of about 3 inches per second is the minimum buoyancy a pill should have to give positive floating on a swallow of water in the mouth. This corresponds to a density of about 0.95 for all the sizes of capsules tested. The 0.95 density line is the upper limit of demarkation of the preferred area on the density-volume graph in FIGURE 3. This shaded area 50 extends down to the curve 20 representing approximately the minimum density, for each size of capsule, which does not begin to give an objectionable degree of mouth sensation. A pill falling anywhere in that shaded area 50 will give good performance in swallowing by the bowed head method, with little or no mouth sensation.
According to this invention, solid medicinals of all forms, including capsules, pills, tablets, and the like, are formulated and fabricated to have optimum density for swallowing by the bowed head method. Various procedures which may be used include the following:
(1) Use of gelatin capsules filled with the proper amount of the medicinal to give the desired density. Normally this can be readily accomplished by inclusion of air with the solid material.
(2) Preparation of pills or tablets having a void in the center filled with air, or suitable low density material, to adjust the density of the tablet, etc., to the desired optimum. This can be accomplished by cementing together two preformed halves.
(3) Preparation of the pill or tablet by compounding the active ingredient with an admixture or inclusion of suitable solid low density excipient materials, in sufiicient amount to give the desired density, such as precipitated chalk, silica gel, corn starch, Irish moss, agar gel, and methyl cellulose. These materials may be added to the medicinal in sufficient amount to give the desired overall density of the pill.
(4) Application to the outside of a preformed tablet, of a low density coating, to reduce the average density to the desired value. For example, a preformed pill may be coated with an adhesive solution such as gelatin, albumen, or methyl cellulose, and then dipped in any one of the above mentioned low density materials in finely divided or powder form. In order to obtain a suficient quantity of the low density material on the surface of the pill, it may be necessary to repeat the operation. Another method is to coat the pill with a foamed coating based on gelatin or albumen, or methyl cellulose. A specific coating which was found to be satisfactory was prepared as follows:
70 grams of albumen (egg white) was beaten to a stiff foam using a high speed mechanical mixer.
A solution of 480 grams of surcose in grams water and grams corn syrup was boiled, with loss of water, until the boiling point reached 256 F. This hot solution was then slowly poured into the beaten egg white with continued mixing.
This method produced a stabilized foam, which was suitable for application as a coating to a preformed pill or tablet. After coating, the pills were allowed to dry at low humidity and room temperature until the surface was smooth and nontacky. Pills may be held for dipping by impaling on needles, or for more refined manufacture may be held on the end of small vacuum tubes. One side is dipped, the coating dried, then the pills are reversed and the remaining portion coated and dried to give a completely coated, smooth surfaced pill. As the batch of frothy coating cools it increases in viscosity, which increases the amount picked up on the surface of the pill when it is dipped. The viscosity of the coating batch, and the resultant thickness of the coating on the pill may be controlled by controlling the temperature of the batch. A 2 mm. thick coating applied to a 5 grain aspirin tablet imparted very adequate buoyancy in water.
(5) Preparation of the tablet by compounding with, or by overcoating with a system of bicarbonates admixed with citric acid or tartaric acid, which will produce effervescence when placed in water, due to the evolution of carbon dioxide. The evolved gas gives the buoyancy required to float the tablet. It is desirable to provide a coating of a water-permeable, film-forming material on the outside of the tablet to retain the gas under this exterior skin and give more stable buoyancy during swallowing. The following is an illustrative procedure:
A suitable effervescing salt is prepared from either of the following mixtures of ingredients:
Parts Sodium bicarbonate 84 Citric acid 7O Powdered sugar 80 Sodium bicarbonate 84 Tartaric acid 75 Powdered sugar 80 The ingredients of either mixture are slowly heated to 220 F. The mass becomes soft and sticky. Granulation of the mass is effected by stirring or kneading in acid resistant equipment. The mass is removed from the heat and the stirring continued until it is cool. The resulting granules are then thoroughly dried and mechanically reduced to a fine powder. The powder is protected from contact with moisture or humid air to prevent loss of effervescence when used in water.
A solution for adhering the above elfervescing powder to the surface of a pill is prepared by dissolving sutficient methyl cellulose, Dow Chemical Company Methocel GOHG (400 cps. viscosity grade) in ethyl lactate to give a 2% solution by weight. The Methocel is dissolved in the ethyl lactate by heating to about 150 F. This solution is then cooled to about 100 F., or to a temperature that gives a suitable solution viscosity for dipping of the pills. The pill to be coated is immersed in or sprayed with this solution, then dried just sufficiently to present a tacky surface. The pill is then rolled in the effervescing powder to completely cover the tacky coating. Slow drying is then used to remove most of the solvent. The pill is then given a protective exterior coating by immersing or spraying with the same solution. The solvent is now completely removed by drying. When immersed in water, the methyl cellulose coating passes water to the effervescing salt, which evolves carbon dioxide, and produces buoyancy of the pill. The gel of Methocel formed on the outside of the pill when immersed in water tends to trap the evolved carbon dioxide. This stabilizes the buoyancy of the pill for more positive performance during swallowing.
Examples of pills, capsules, etc., which are suitable for use by the bowed head method of swallowing may be selected by reference to FIGURE 3. A capsule with a volume of 1.6 cc. should have a density of approximately 0.8 to approximately 0.9 in order to have adequate buoyancy to give positive, and rapid floating on a swallow of water, without excessive buoyancy which will give rise to mouth sensation. Likewise, a capsule having a. volume of 0.8 cc. should have a density of approximately 0.65 to approximately 0.8.
It is to be understood that for each volume of capsule, pill, etc., there is a range of densities from the sensation objectionable line to the 1.0 density level, within which solid medicinals can be made which will function with the bowed head method of swallowing. For optimum results, however, it is preferred to select a density which falls within the shaded area surrounding the no sensation line. Obviously, the limiting maximum density is 1.0, but as the density of any capsule, pill, etc., approaches this value, the sluggish buoyancy may result in swallowing failure using the bowed head method.
It is therefore evident that the discovery of the bowed hea method of swallowing solid medicinals having selected density in relation to volume, provides a new and useful improvement in the technique of administering solid preparations to patients. This enables the avoidance of the troubles encountered in pill swallowing such as sticking to the tongue, lodging in the throat or esophagus, gagging and choking, need for multiple tries, and disintegration of pills held too long in the mouth, with the resultant unpleasantness. It will be a service to patients for whom pill swallowing is a difficult and most unpleasant necessity. It will be welcomed by mothers who must administer pills to children. The technique is readily learned, there is little or no sensation, hence it develops no apprehension nor resistance. This method, and the availability of suitable preparations, should be welcomed by office workers, and others who take pills with water from a bubbler type drinking fountain. This puts the head in exactly the right position for swallowing by this method, and the pill can be swallowed without attracting any attention, as when the head is tipped back.
The expression pill or tablet as used herein is intended to include medicinals in capsules or in the form of pills, tablets, troches, lozenges and pellets of any suitable shape.
1. The method of swallowing a pill by a human subject which comprises the steps of taking a single swallowable amount of a liquid in the mouth together with a pill having a density in the range from about 0.4 to about 0.95, and a volume in the range from about 0.2 cubic centimeters to about 1.7 cubic centimeters, as shown by the shaded area 50 of FIGURE 3, then bowing the head downwardly and forwardly while retaining said liquid and pill in the mouth, and then swallowing same while the head is held in said downwardly bowed position.
2. The method of swallowing a pill by a human subject which comprises the steps of taking a single swallowable amount of a liquid in the mouth together with a pill having a density in the range from about 0.4 to about 0.95, and a volume in the range from about 0.2 cubic centimeter to about 1.7 cubic centimeters, as shown by the shaded area 50 of FIGURE 3, retaining the liquid and pill in the mouth with closed lips while the head of the subject is held in normal upright position, then bowing the head downwardly and forwardly so that the closed lips of the subject are moved downwardly in an arc of approximately from the said upright position, then swallowing the liquid and pill while the head is retained in said downwardly bowed position.
3. The method of swallowing a pill by a human subject which comprises taking a single swallowable amount of a liquid in the mouth together with a pill having a density in the range from about 0.4 to about 0.95, and a volume in the range from about 0.2 cubic centimeter to about 1.7 cubic centimeters, as shown by the shaded area 50 of FIGURE 3, while the head is bowed downwardly and forwardly and swallowing the said liquid and pill while the head is held in said bowed position.
References Cited UNITED STATES PATENTS 2,797,201 6/1957 Veatch et a1 16783 XR 2,841,528 7/1958 Myhre 167-82 3,012,893 12/1961 Krenzner et al. 99-134 LEWIS GOTTS, Primary Examiner.
SHEP K. ROSE, Assistant Examiner.
US. Cl. X.R. 424-14