JP2023083230A - Film used for wrapping molding comprising medicinal component - Google Patents

Abstract

To provide a film that can form a cup part for wrapping a molding comprising a medicinal component with high moldability, wherein the film can be used in producing a tablet to disintegrate in a shorter time.SOLUTION: Disclosed is a film used for wrapping a molding comprising a medicinal component. The film comprises at least one polymer of hypromellose or hydroxypropylcellulose, the content of the polymer being 35 mass%-95 mass% relative to the total amount of the film. The 2 mass% aqueous solution of the hypromellose has a viscosity of 7 mPa s or more at 20°C. The 2 mass% aqueous solution of the hydroxypropylcellulose has a viscosity of 2 mPa s or more at 20°C.SELECTED DRAWING: Figure 1

Description

The present invention provides a film used for wrapping a molded body containing a medicinal ingredient, a method for producing a tablet, a tablet, and a method for improving the shape retention, physical stability and / or chemical stability of the tablet. Regarding.

An orally disintegrating tablet (OD tablet) is an oral preparation that rapidly disintegrates with saliva or a small amount of water in the oral cavity, and is a dosage form that is highly needed by children and patients with impaired swallowing function. However, since tablet hardness is lower and friability is higher than that of general formulations, tablets may crack or chip during the manufacturing process or during packaging. In addition, many of them have high hygroscopicity, and moisture absorption tends to cause delay in disintegration and decrease in hardness.

One of the methods for protecting oral preparations from quality deterioration is a method of wrapping a molded article containing a medicinal ingredient with a thermoplastic sheet or film. In order to produce such a formulation, a cup portion having an opening is formed by pressing a thermoplastic sheet or film against a mold, a molded article containing a medicinal ingredient is inserted into the cup portion, and then the cup portion is A method of forming a lid portion that seals the opening of is being studied (Patent Documents 1 to 3).

WO2018/074259 WO2018/074260 WO2018/074261

The present inventors tried wrapping the OD tablet with a thermoplastic sheet or film. However, disintegration delay may occur due to the solubility of the sheet or film, and it has been difficult to wrap the OD tablet without impairing its excellent disintegration properties.

Therefore, one aspect of the present invention is a film capable of forming a cup portion for containing a molded body containing a medicinal ingredient with excellent moldability, and is used for the production of tablets that disintegrate in a shorter time. We provide films that can

One aspect of the present invention is a film containing at least one polymer of hypromellose or hydroxypropylcellulose, wherein the content of the polymer is 35% by mass to 95% by mass based on the total amount of the film, and A 2% by mass aqueous solution of hypromellose has a viscosity at 20° C. of 7 mPa·s or more, and a 2% by mass aqueous solution of hydroxypropylcellulose has a viscosity of 2 mPa·s or more at 20° C. Wrapping a molded body containing a medicinal ingredient. provides a film used for

Another aspect of the present invention is to form a cup portion forming an opening, to accommodate a molded body containing a medicinal ingredient in the cup portion, and to cover the opening with a lid portion covering a film for the lid portion. thereby wrapping the molded body with the lid portion and the cup portion, wherein the cup portion molds the film according to one aspect of the present invention that has been heated, or a medicinal ingredient To provide a method for producing a tablet formed by pressing against a molded body containing

Yet another aspect of the present invention provides a tablet comprising a molded body containing a medicinal ingredient, a cup portion containing the molded body and forming an opening, and a lid closing the opening. The cup portion is the film according to one aspect of the present invention.

Yet another aspect of the present disclosure includes wrapping a molded body containing a medicinal ingredient with one or more films including the film according to one aspect of the present invention, tablet shape retention, physical stability Provided are methods for improving the properties and/or chemical stability.

According to one aspect of the present invention, there is provided a film capable of forming a cup portion for containing a molded body containing a medicinal ingredient with excellent moldability, and is used for the production of tablets disintegrating in a shorter period of time. Provided is a film capable of

BRIEF DESCRIPTION OF THE DRAWINGS It is a schematic diagram which shows an example of the method of manufacturing a tablet. BRIEF DESCRIPTION OF THE DRAWINGS It is a schematic diagram which shows an example of the method of manufacturing a tablet.

Several embodiments of the invention are described in detail below. However, the present invention is not limited to the following embodiments.

FIG.1 and FIG.2 is a schematic diagram which shows an example of the method of manufacturing a tablet. The method shown in FIGS. 1 and 2 includes preparing a cup portion film 1 as shown in (a), and heating the cup portion film 1 as shown in (b) and (c). is pressed against the mold 30 to form the cup portion 10 forming the opening, and as shown in (d), the remaining portion 1C of the cup portion film 1 other than the cup portion 10 is removing so that the part remains, accommodating the granular molded body 5 containing the medicinal ingredient in the cup part 10 as shown in (e), and the cup part film 1 as shown in (f) The remaining portion 1C other than the cup portion 10 is removed, and the lid portion 20 that closes the opening of the cup portion 10 is formed from the lid portion film 2 as shown in (g), thereby forming the lid portion 20 and the cup Wrapping the molding 5 with the portion 10 and removing the remaining portion 2C of the lid portion film 2 other than the lid portion 20 as shown in (h) are included in this order. Here, "wrapping the molded article" means enclosing the molded article in one or more films.

The cup portion film 1 according to one embodiment is a single-layer film containing at least one polymer of hypromellose and hydroxypropylcellulose.

In one embodiment, a 2% by weight aqueous solution of hypromellose has a viscosity at 20° C. of 7 mPa·s or more. The viscosity of the 2% by mass aqueous solution of hypromellose at 20° C. may be 8 mPa s or more, 9 mPa s or more, or 10 mPa s or more, for example, 20 mPa s or less, 18 mPa s or less, or 16 mPa s. It may be below.

In one embodiment, the viscosity of a 2% by weight aqueous solution of hydroxypropylcellulose at 20° C. is 2 mPa·s or more. The viscosity of the 2% by mass aqueous solution of hydroxypropylcellulose at 20° C. may be 6 mPa·s or more, 7 mPa·s or more, or 8 mPa·s or more, for example, 20 mPa·s or less, 18 mPa·s or less, or 16 mPa. * It may be less than or equal to s.

The viscosity of a 2% by weight aqueous solution of hypromellose or hydroxypropylcellulose is a value that mainly depends on the molecular weight of these polymers. A 2% by weight aqueous solution contains substantially only these polymers and water. 2% by weight is the concentration of polymer based on the weight of the aqueous solution. The viscosity of a 2% by mass aqueous solution can also be adjusted by mixing two or more polymers (for example, Shin-Etsu Chemical Co., Ltd. medical technical data "M-001 METOLOSE (registered trademark) METOLOSE (registered trademark )” (Cellulose Department, October 2009)). As used herein, the viscosity of hypromellose means a value measured by a capillary viscometer or a rotational viscometer (e.g., B-type rotational viscometer), and the viscosity of hydroxypropylcellulose is a rotational viscometer (e.g., B type rotational viscometer).

When the cup portion film 1 contains both hypromellose and hydroxypropyl cellulose, the viscosity at 20° C. of a 2% by mass aqueous solution of a mixture of hypromellose and hydroxypropyl cellulose (hereinafter also simply referred to as “polymer mixture”) is 2 mPa·s. 6 mPa s or more, 7 mPa s or more, 8 mPa s or more, 9 mPa s or more, or 10 mPa s or more, and 20 mPa s or less, 18 mPa s or less, or 16 mPa s or less. may A 2% by weight aqueous solution contains substantially only polymer and water. 2% by weight is the concentration of the polymer mixture based on the weight of the aqueous solution. The 2% by mass aqueous solution of the polymer mixture contains 2% by mass of a mixture obtained by mixing hypromellose and hydroxypropyl cellulose at the same ratio as the content ratio of these polymers in the film 1 for the cup portion. The viscosity of a 2% by mass aqueous solution of the polymer mixture means a value measured with a B-type rotational viscometer.

In one embodiment, the content of the polymer is 35% by mass to 95% by mass based on the total amount of the cup portion film 1. The content of the polymer may be 40% by mass or more or 45% by mass or more based on the total amount of the cup portion film 1, and is 90% by mass or less, 85% by mass or less, 80% by mass or less, or 75% by mass or less. , 70% by mass or less, 65% by mass or less, 60% by mass or less, or 55% by mass or less. The content of hypromellose or hydroxypropylcellulose may be 35% by mass or more, 40% by mass or more, or 45% by mass or more, respectively, and 95% by mass or less, 90% by mass or less, 85% by mass or less, and 80% by mass. 75% by mass or less, 70% by mass or less, 65% by mass or less, 60% by mass or less, or 55% by mass or less.

In one embodiment, the cup portion film 1 may contain an excipient, a plasticizer, or other components having both functions. Examples of ingredients that function as excipients include inorganic excipients such as titanium oxide, calcium carbonate, talc, light anhydrous silicic acid, and silicon dioxide; sugars such as crystalline cellulose, sucrose, lactose, maltose, and trehatose; sugar alcohols such as glycerin, sorbitol, mannitol, erythritol and xylitol; and starches such as corn starch and potato starch. Examples of other ingredients with plasticizer functionality include triethyl citrate, triacetin, propylene glycol, polyethylene glycol, and sugar alcohols.

In one embodiment, the cup film 1 may contain at least one other component selected from the group consisting of triethyl citrate, triacetin, propylene glycol, polyethylene glycol, sugar alcohol, titanium oxide, calcium carbonate and sugars. good. The saccharide may be maltose and/or trehalose. The molecular weight of polyethylene glycol may be 10000 or less from the viewpoint of moldability of the cup portion film 1 and the like. Sugar alcohols may be, for example, glycerin, sorbitol, erythritol, or xylitol.

The content of the other components may be, for example, 5% by mass to 65% by mass based on the total amount of the cup portion film 1. The content of other components is 10% by mass or more, 15% by mass or more, 20% by mass or more, 25% by mass or more, 30% by mass or more, 35% by mass or more, and 40% by mass, based on the total amount of the cup portion film 1. % or more or 45 mass % or more, and may be 60 mass % or less or 55 mass % or less.

In addition to the polymers and other components exemplified above, the cup portion film 1 may further contain other additives within a range that does not impair film-forming properties and moldability. Examples of other additives include flavoring agents, disintegrants, coloring agents and flavoring agents. The content of other additives may be 10% by mass or less, 5% by mass or less, 3% by mass or less, or 1% by mass or less based on the mass of the cup portion film 1 .

The thickness of the cup portion film 1 may be, for example, 20 to 60 μm, or 10 to 100 μm. The thickness of the cup portion film 1 may be 25 μm or more or 30 μm or more, and from the viewpoint of improving the disintegration property of the tablet 50 (described in detail later) containing the cup portion film 1, it is 50 μm or less and 45 μm or less. , or 40 μm or less.

The cup portion film is not limited to a film consisting of only a single layer cup portion film 1 as in the example shown in FIG. For example, the cup portion film may have a base film containing the above-described polymer and additive, and an adhesive layer provided on the base film. When the adhesive layer is provided, the cup portion 10 and the lid portion 20 can be joined more firmly. In addition, when the cup portion 10 is formed by the molded body 5 instead of the mold 30 (details will be described later), the molded body 5 and the cup portion 10 can be firmly bonded by providing an adhesive layer. The adhesive layer may be, for example, a layer containing copolyvidone, polyvinylpyrrolidone.

The cup portion film 1 is formed by, for example, applying a coating liquid containing a polymer, other components and other additives added as necessary, and water to a substrate having a smooth flat surface such as a glass plate. , and drying the coating film.

By pressing the heated cup portion film 1 against the mold 30 and applying a negative pressure to the space between the cup portion film 1 and the mold 30, the bottom portion 1A and the wall portion 1B extending from the peripheral edge of the bottom portion 1A are formed. , a cup portion 10 is formed having an opening formed by the end of the wall portion 1B. Although not shown in the figure, the heated cup portion film 1 is pressed against the molded body 5 containing the medicinal ingredient described later instead of the mold 30, and the gap between the cup portion film 1 and the molded body 5 is formed. The cup portion 10 can also be formed by making the pressure negative. In this case, the molded body 5 is accommodated in the cup portion 10 at the same time when the cup portion 10 is formed. In order to press the mold 30 or the molded body 5 against the cup film 1, the mold 30 or the molded body 5 may be moved toward the fixed cup film 1, and the fixed mold 30 or molded body 5, the cup part forming film 1 may be moved.

At the time when the mold 30 is separated from the cup portion film 1 or when the formation of the cup portion 10 is completed, the remaining portion 1C of the cup portion film 1 other than the cup portion 10 is normally formed around the cup portion 10. to some extent. The shape and size of the cup portion 10 are adjusted so that the molded body 5 can be accommodated therein. The bottom portion 1A may be curved as shown, or may be planar. The maximum value of the depth of the cup portion 10 (the depth from the remaining portion 1C) may be, for example, 8 mm or less. The maximum width of the cup portion 10 (the maximum distance between the inner surfaces of the cup portion 10 when viewed from the depth direction of the cup portion 10) may be, for example, 16 mm or less.

The temperature (molding temperature) of the cup portion film 1 pressed against the mold 30 or the molded body 5 is a temperature adjusted so that the desired shape of the cup portion 10 is appropriately formed. It is the temperature at which the temperature of the part film 1 is 80 to 170°C, or 90 to 160°C. The time for which the mold 30 or the molding 5 is pressed against the cup portion film 1 may be within a range that does not affect the normal formation of the film.

After the cup portion 10 is formed, most of the remaining portion 1C around the cup portion 10 is removed. For this purpose, for example, the cup portion film 1 may be cut along the opening of the cup portion 10 by irradiation with a laser beam.

When the cup portion 10 is formed by the mold 30 , the cup portion 10 then accommodates the molded body 5 containing the medicinal ingredient. As described above, when the cup portion 10 is formed by the molded body 5 instead of the mold 30, the molded body 5 is accommodated at the same time as the cup portion 10 is formed. The molded body 5 can be formed, for example, by compression molding of powder containing a medicinal component and other components added as necessary. The compact may have a split line. Examples of ingredients other than active ingredients include excipients, binders, disintegrants, colorants, flavoring agents, flavoring agents, lubricants, stabilizers, and preservatives. The maximum width of the molded body 5 is generally about the same as the maximum width of the cup portion 10 .

After the molding 5 is accommodated in the cup portion 10, the remaining portion 1C is removed by a method such as laser light irradiation.

The heated lid film 2 is pressed against the exposed surface of the cup portion 10 containing the molded body 5 . By applying a negative pressure to the resulting air gap between the lid film 2 and the cup portion 10 , the lid portion is formed and the lid portion film 2 is joined to the cup portion 10 . In the lid film 2, the entire surface of the molded body 5 is covered with the lid part 20 composed of the ceiling part 2A covering a part of the surface of the molded body 5 and the wall part 2B extending from the peripheral edge thereof, and the cup part 10. . In other words, the molded body 5 is wrapped by the lid portion 20 and the cup portion 10 .

The temperature (molding temperature) of the lid portion film 2 pressed against the cup portion 10 containing the molded body 5 is adjusted so that the lid portion 20 having a desired shape is appropriately formed. For example, the molding temperature may be 80-170°C, or 90-160°C.

The lid film 2 is a thermoplastic film, and may be the same film as the cup film 1, for example. Since the inner surface of the wall portion 2B of the lid portion 20 and the outer surface of the wall portion 1B of the cup portion 10 are adhered, the lid portion 20 (the lid portion film 2) is made of the same base as the cup portion film 1. It may have a material film and an adhesive layer provided on the inner surface of the base film.

After the lid portion 20 is formed, the remaining portion 2C of the lid portion film 2 other than the lid portion 20 is removed by a method such as laser light irradiation.

After that, by performing a treatment such as heat shrinkage as necessary, the molded body 5, the cup part 10 containing the molded body 5, and the lid joined to the cup part 10 so as to enclose the molded body 5 A tablet 50 is obtained, consisting of part 20.

Tablet 50 may be, for example, an orally disintegrating tablet. The disintegration time of tablet 50 in water at 37° C.±2° C. may be, for example, 60 seconds or less, 55 seconds or less, or 50 seconds or less. As used herein, the disintegration time means the time required for the tablet 50 to completely disintegrate when tested with a disintegration tester (Toyama Sangyo NT-60H). More specifically, it means the time from when the glass tube containing the tablet is lowered into the beaker and the test is started until the shape of the tablet is not observed in the glass tube at all. If the disintegration time is 50 seconds or less, or 40 seconds or less, the tablet 50 can be particularly suitably used as an orally disintegrating tablet.

The dissolution time of the cup portion 10 in the tablet 50 is obtained by measuring the disintegration time of the tablet 50, separately measuring the disintegration time of the molded body 5, and subtracting the disintegration time of the molded body 5 from the disintegration time of the tablet 50. be able to. In order to make the disintegration time of tablet 50 in 37°C ± 2°C water 60 seconds or less, the dissolution time of cup portion 10 in 37°C ± 2°C water depends on the disintegration time of compact 5. is preferably 50 seconds or less, more preferably 40 seconds or less, even more preferably 30 seconds or less.

The oral disintegration time of tablet 50 may be, for example, 60 seconds or less, 50 seconds or less, 40 seconds or less, or 30 seconds or less. As used herein, the oral disintegration time means the time required for the tablet 50 to completely disintegrate with saliva without taking water. More specifically, it means the time from when the tablet is placed in the oral cavity to when it reaches a dispersed state in which it can be swallowed only with saliva without chewing without taking water. If the oral disintegration time is 50 seconds or less, or 40 seconds or less, the tablet 50 can be particularly suitably used as an orally disintegrating tablet.

By wrapping a molded article containing a medicinal ingredient with two films composed of the cup portion film 1 and the lid portion film 2, the molded article has shape retention properties such as shape retention and anti-friction strength. Or, even if the physical and chemical stability of the compact is insufficient, a tablet that can be stably handled can be obtained. Therefore, the film according to this embodiment can also be used to improve the shape retention, physical stability and/or chemical stability of existing tablets having a molded body containing a medicinal ingredient.

EXAMPLES Hereinafter, the present invention will be described more specifically with reference to examples. However, the present invention is not limited to these examples.

1. Ingredient Hypromellose (Hydroxypropyl methylcellulose)
・ TC-5S (Viscosity of 2% by mass aqueous solution (20 ° C.): 15 mPa s, Shin-Etsu Chemical Co., Ltd.)
・ TC-5R (Viscosity of 2% by mass aqueous solution (20 ° C.): 6 mPa s, Shin-Etsu Chemical Co., Ltd.)
・ TC-5E (Viscosity of 2% by mass aqueous solution (20 ° C.): 3 mPa s, Shin-Etsu Chemical Co., Ltd.)
Hydroxypropyl cellulose, HPC-L (Viscosity of 2% by mass aqueous solution (20° C.): 6.0 to 10.0 mPa s, Nippon Soda)
・ HPC-SSL (Viscosity of 2% by mass aqueous solution (20 ° C.): 2.0 to 2.9 mPa s, Nippon Soda)
Other ingredients ・Titanium oxide (Freund Corporation)
・Calcium carbonate (Shiraishi calcium)
・Maltose (Hayashibara)
・Trehalose (Hayashibara)
・Triethyl citrate (Morimura Corporation)
・Triacetin (Kanto Chemical)
・Concentrated glycerin (Kanto Chemical)
・PEG400 (Sanyo Kasei, polyethylene glycol, average molecular weight 400)
・Propylene glycol (Kanto Chemical)

2. Production of Film A coating solution containing each raw material with the formulation shown in Tables 1 to 4 was prepared by the following procedure. The formulations described in each table are shown as percentages (% by mass) based on the total amount of raw materials (polymer (hypromellose or hydroxypropylcellulose) and other ingredients). “Viscosity A” is the viscosity at 20° C. of a 2% by weight aqueous solution of hypromellose or hydroxypropylcellulose measured with a capillary viscometer. "Viscosity A" in Examples 4 to 6 and Comparative Example 3 is "M-001 METOLOSE (registered trademark) Viscosity adjustment by blending METOLOSE (registered trademark)" (cellulose (October 2009)), it is a value obtained from the mixing ratio of hypromellose TC-5S and TC-5R. In each table, "viscosity B" is a value obtained by measuring the viscosity of a 2% by mass aqueous solution of hypromellose or hydroxypropylcellulose at the measurement temperature shown in the table with a B-type rotational viscometer. Regarding the viscosity at 20° C. of 2% by mass of hypromellose, the value measured by the capillary type viscometer and the value measured by the B-type rotational viscometer were equivalent. In Example 13, the viscosity of the 2% by mass aqueous solution of the polymer mixture was measured at 19.8° C. with a B-type rotational viscometer and found to be 13.5 mPa·s. For the preparation of the coating liquid, other components were first dissolved in a mixed solvent of purified water/ethanol (mass ratio: 70/30). Hypromellose or hydroxypropyl cellulose was dissolved in the obtained aqueous solution to obtain a coating liquid for film formation. After the coating solution was deaerated under vacuum, it was applied to a glass plate with a constant thickness using an electric film applicator. The coating film was dried in a drier at 50° C. to prepare a film having a thickness of 40 μm or 30 μm (films according to Comparative Examples 1 to 5 and Examples 1 to 17).

3. Evaluation of film 3-1. Film formability 2. After making the film according to the procedure above, when peeling off the film from the glass plate, "Good" means that the film can be peeled off without cracking, etc., and "Bad" means that it cannot be peeled off due to cracking " The results are shown in Tables 1-4.

3-2. Cracks When the obtained film was bent, it was rated as "yes" if it was broken or cracked, and as "no" if it was not broken or cracked. Films evaluated as "poor" in film-forming properties were excluded from this evaluation. The results are shown in Tables 1-4.

3-3. Formability Using a wrapping preparation manufacturing apparatus equipped with a heater for heating the film, conforming to the wrapping tablet manufacturing method described in the mode for carrying out the invention in WO 2018/074261, inner diameter 7.5. A cup portion was formed by pressing a mold with a 5 mm cylindrical portion against the film and applying a negative pressure to the air gap between the film and the mold. The set temperature of the heater for heating the film is 240 to 400°C, the temperature at the heater outlet at that time is 190°C to 300°C, and the temperature near the upper surface of the film at that time is 110 to 170°C. At this time, the temperature of the lower surface of the film was 80 to 140°C at maximum. A case where a cup portion having a shape that perfectly reflects the wall surface of the cylindrical portion of the mold was formed was judged to be "acceptable", and a cup portion having a shape wider than the inner diameter of the cylindrical portion of the mold was formed. The case was judged as "impossible". The films according to Comparative Examples 1, 3, and 4 were severely cracked during film cracking evaluation, were judged unsuitable for forming a cup portion, and were excluded from this evaluation. The results are shown in Tables 1-4.

4. Preparation of Tablets Tablets were prepared by the following procedure using the films (films according to Examples 1 to 17) whose moldability was evaluated as "good" as the films for the cup portion and the lid portion. First, using a tableting machine (Kikusui Seisakusho Virgo (registered trademark)), 200 mg of powder obtained by adding 0.5% by mass of magnesium stearate to Granfiller D (Daicel Co., Ltd.) is compression molded at 10 kN ( φ8.0 mm, R12). Subsequently, the heated film was pressed against the molded body, and the gap between the resulting film and the molded body was made negative pressure to mold the cup portion and accommodate the molded body in the cup portion. Afterwards, the unnecessary film was cut off to obtain a tablet in which a portion of the compact was wrapped. Thereafter, the lid portion is formed and the lid portion and the cup portion are joined together by a method conforming to the method for manufacturing a wrapping lock described in the mode for carrying out the invention in International Publication No. 2018/074261. The film was cut off to obtain a tablet for evaluation in which the molded body was wrapped with a lid and a cup.

5. Evaluation of tablets 5-1. Disintegration (disintegration time)
The disintegration time in water at 37°C ± 2°C was measured using a disintegration tester (Toyama Sangyo NT-60H). The tablets were placed in a glass tube fitted with a mesh permeable to water at one end. The glass tube containing the tablets was lowered into water at 37°C ± 2°C in a beaker, and the tablets were immersed in the water that had passed through the mesh. The time from when the glass tube was lowered into the water to when no shape of the tablet was observed in the glass tube was measured. The average value of the time measured for 6 tablets was taken as the disintegration time. The results are shown in Tables 1-4. 4 above. (not wrapped with a film) was measured in the same manner, and the disintegration time was 16 seconds.

5-2. Film dissolution time 5-1. The dissolution time of the film forming the cup portion and lid portion of the tablet was obtained by subtracting the disintegration time of the compact (16 seconds) from the disintegration time of each tablet obtained in the procedure of . The results are shown in Tables 1-4.

5-3. Oral disintegration (oral disintegration time)
The intraoral disintegration time of the produced tablet was measured. Specifically, the time from when the tablet was placed in the oral cavity until it reached a dispersed state in which it could be swallowed only with saliva without chewing without taking water was measured. The results are shown in Tables 1-4.

DESCRIPTION OF SYMBOLS 1... Cup part film, 1A... Bottom part, 1B... Wall part, 1C... Remaining part, 2... Lid part film, 2A... Ceiling part, 2B... Wall part, 2C... Remaining part, 5... Molded body, 10... Cup part , 20... Lid portion, 30... Mold, 50... Tablet.

Claims (10)

A film comprising at least one polymer of hypromellose or hydroxypropylcellulose,
The content of the polymer is 35% by mass to 95% by mass based on the total amount of the film,
The viscosity of the 2% by mass aqueous solution of hypromellose at 20° C. is 7 mPa s or more,
The viscosity of the 2% by mass aqueous solution of hydroxypropyl cellulose at 20° C. is 2 mPa s or more.
A film used for wrapping molded articles containing medicinal ingredients. 3. The film of claim 1, further comprising excipients, plasticizers, or other ingredients that function both. 2. The film according to claim 1, further comprising at least one other ingredient selected from the group consisting of triethyl citrate, triacetin, propylene glycol, polyethylene glycol, sugar alcohol, titanium oxide, calcium carbonate and sugars. For producing a tablet by a method comprising pressing the heated film against a mold or a molded body containing a medicinal ingredient to form a cup portion for accommodating the molded body containing the medicinal ingredient A film according to any one of claims 1 to 3, which is used. forming a cup portion defining an opening;
housing a molded body containing a medicinal ingredient in the cup;
Forming a lid portion that closes the opening with a lid portion film, thereby wrapping the molded body with the lid portion and the cup portion;
including
The cup portion is formed by pressing the heated film according to any one of claims 1 to 3 against a mold or the molded body,
A method of manufacturing tablets. 6. The method of claim 5, further comprising removing the remainder of the film other than the cup portion after the molded body is accommodated in the cup portion. a molded body containing a medicinal ingredient;
a cup portion containing the molded body and forming an opening;
a lid that closes the opening;
with
The molded body is wrapped by the lid portion and the cup portion,
The cup portion is the film according to any one of claims 1 to 3,
tablet. 8. The tablet according to claim 7, wherein the dissolution time of the cup portion in water at 37°C ± 2°C is 40 seconds or less. 8. The tablet according to claim 7, wherein the tablet has a disintegration time in water at 37[deg.]C ± 2[deg.]C of 60 seconds or less. Forming body containing a medicinal ingredient, comprising wrapping with one or more films containing the film according to any one of claims 1 to 3, tablet shape retention, physical stability and / or chemical How to improve stability.

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