WO2016161830A1

WO2016161830A1 - Drug release strip

Info

Publication number: WO2016161830A1
Application number: PCT/CN2016/070662
Authority: WO
Inventors: 王善春; 李昌辉; 张喜全; 顾红梅; 王昌良; 董平
Original assignee: 正大天晴药业集团股份有限公司
Priority date: 2015-04-09
Filing date: 2016-01-12
Publication date: 2016-10-13

Abstract

Provided is a drug release strip for releasing drug powder or particles (10) in a fixed dose. The drug release strip (1) is formed by a substrate (11) and a cover sheet (12) closely attached to each other. The substrate (11) is provided with a plurality of blisters (111) thereon. The drug (10) is sealed in the blisters (111) by the substrate (11) and the cover sheet (12). The substrate (11) and the cover plate (12) at a release end of the drug release strip (1) are structurally separated, and rear ends of the substrate (11) and the cover plate (12) structurally separated are respectively wound around a slit (21) of a substrate winding wheel (20) and a cover sheet winding wheel (30). The drug release strip is characterized in that the rear end of the substrate (11) is stamped and formed with a protrusion portion (112) capable of being fastened to the slit (21). The drug release strip provides the protrusion portion (112) capable of being formed via a standardized processing, and is easily installed and fixedly fastened. In addition, the size and shape of the drug blister (111) are optimized, such that the drug (10) is easier to be inhaled, and an effective usable length of the drug release strip (1) is increased.

Description

Drug release tape

Technical field

The present invention relates to a blister strip for the release of a powder or granulated medicament, and more particularly to a medicinal release strip which can be used for asthma inhalation of powder or granules.

Background technique

Allergic diseases such as asthma and rhinitis are often treated with inhaled drugs, such as placing powder or granular drugs in a blister strip of a sandwich structure, piercing the blister strip by external force, and then inhaling the drug by inhalation. The patient's mouth, nose or lungs are used for therapeutic purposes.

The existing drug release tape is composed of a substrate and a cover sheet which are in close contact with each other, wherein a plurality of blister sheets are formed on the substrate, and a powder or granular drug for treating asthma or rhinitis is sealed in the blister by the substrate and the cover sheet. The substrate and the cover sheet of the release end of the drug release tape have a separated structure, and the substrate and the cover sheet having the separated structure are wound around the slit of the substrate winding wheel and the cover sheet winding wheel, and wound by the substrate. The rotation of the wheel and the cover sheet winding wheel gradually separates the substrate and the cover sheet to expose the medicine in the medicine bubble, so that the exposed medicine can be inhaled into the patient's nose, mouth or lung by the patient inhaling, and the patient sucks. At the time of gas, the airflow enters the medicated bubble of the drug release tape through the air inlet of the drug release device and impacts the drug powder at one end thereof to form a U-shaped airflow to blow up the powder in the medicated bubble and entrain it, and then through the docking medicated bubble The vent at one end is inhaled into the patient.

The above-mentioned prior art drug release tape has the following problems:

1. When the substrate of the drug release tape is fitted with the slit on the substrate winding wheel, the end of the substrate must be folded and wound onto the rotating shaft of the substrate winding wheel by means of an external force or an appliance to prevent the end of the substrate from being narrow. Slippage in the seam, the consequence of this is that the operation of folding the end of the substrate is very random, the end of the substrate is easily detached from the slit, and the assembly process is complicated and cannot be standardized; in addition, the manual or instrument winding base The ends of the sheets are also prone to contamination.

2. In order to reduce the winding diameter of the substrate wound on the rotating shaft, the prior art needs to cut the end of the substrate into a shape with a narrow width, which not only increases the process, but also because the end of the substrate is always wound to the rotating shaft. The outer side allows the winding diameter of the substrate to be never lowered, so that the length of the drug release tape that can be mounted in a limited space is limited, reducing the effective use length of the drug release tape.

3. The drug release tape disclosed in the prior art has a blister length of about 7.5 mm and a width of about 4.00 mm, but does not disclose the height of the blister and other details. In addition, GlaxoSmithKline has been marketed for the treatment of asthma drugs A drug release tape of the same type is also disclosed in the powder discharge device. The drug release tape has a bubble length of 7.56 mm, a width of 3.80 mm, and a height of 2.00 mm. The above-mentioned prior art disclosed bubble size and shape are not reasonable enough, which tends to cause a large airflow resistance, which not only increases the resistance of inhaled powder in asthma patients with low lung capacity, but also deeper vesicles cause powder residue in the emptying of the powder. The problem affects the actual amount of treatment of the patient and may affect the rehabilitation of the patient. In addition, the deeper the bubble also causes the height of the bubble to be larger, which reduces the number of windings of the drug release band and affects the space utilization inside the inhaler. .

Therefore, it is necessary to provide a new drug release tape to overcome the above drawbacks.

Summary of the invention

SUMMARY OF THE INVENTION It is an object of the present invention to provide a drug release tape having a projection at a distal end of the substrate that can be snapped into the slit of the substrate winding wheel to effectively prevent the end of the substrate from slipping out of the slit.

The above object of the present invention can be achieved by the following technical solutions:

The present invention provides a drug releasing tape for quantitatively releasing a powder or a granular drug, the drug releasing tape being composed of a substrate and a cover sheet which are in close contact with each other, and a plurality of medicines are formed on the substrate a bubble, the drug being sealed in the blister by the substrate and the cover sheet, the substrate and the cover sheet of the release end of the drug release tape being separated and separated The substrate and the end of the cover sheet are respectively wound around the slit of the substrate winding wheel and the cover sheet winding wheel, and the end of the substrate is stamped to form a buckle into the slit Protrusion.

In a preferred embodiment, the height of the blister is from 1.60 mm to 1.90 mm, the width of the blister is from 4.06 mm to 5.06 mm, and the length of the blister is from 7.26 mm to 7.86 mm.

In a preferred embodiment, the height of the blister is 1.75 mm, the width of the blister is 4.56 mm, and the length of the blister is 7.56 mm.

In a preferred embodiment, the slit of the substrate winding wheel is disposed on a cylindrical hollow rotating shaft of the substrate winding wheel, and the protrusion has a size larger than the width of the slit and smaller than the cylindrical shape. The inner diameter of the hollow shaft.

In a preferred embodiment, the protrusions are identical in structure to the blister.

In a preferred embodiment, the end of the substrate does not protrude from the outer surface of the cylindrical hollow shaft in a state where the protrusion is caught in the slit.

In a preferred embodiment, the angle between the tangent to the end of the cross-section of the blister and the mid-perpendicular line of the blister is between 35.3 and 37.3.

In a preferred embodiment, the tangent to the end of the cross-section of the blister and the mid-perpendicular line of the blister The angle is 36.3°.

The features and advantages of the drug release tape of the present invention are:

1. The drug release tape of the present invention provides a standardized processing protrusion at the end of the substrate, the protrusion has a simple structure, a strong buckle, is not easily detached from the slit, and is easy to install, and is not easily introduced during the installation process. Contamination, and the protrusion does not cause the substrate winding diameter to become large, increasing the effective use length of the drug release tape.

2. The drug release tape of the present invention has a reasonable size and shape, and has a low airflow resistance when inhaling a drug, so that a respiratory disease patient with a lower lung capacity is more likely to aspirate the drug; in addition, the height of the bubble is effectively reduced. It improves the difficulty of emptying the powder, makes the residual amount of the powder low, and ensures that the patient can obtain a sufficient amount of the medicine; finally, the height of the medicine also reduces the height of the drug release belt, further increasing the release of the drug in the powder. The number of turns wound in the device, thereby increasing the effective length of the drug release tape.

DRAWINGS

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly described below. It is obvious that the drawings in the following description are only some embodiments of the present invention. Other drawings may also be obtained from those of ordinary skill in the art in light of the inventive work.

1 is a schematic view of a drug release device in which a drug release tape of the present invention is placed in the drug release device.

2 is a schematic view showing the internal structure of the drug releasing tape of the present invention placed in a drug releasing device.

Fig. 3 is a schematic view showing the structure of an embodiment of the drug releasing tape of the present invention.

Figure 4 is a top plan view of a blister of a drug release tape of the present invention.

Figure 5 is a schematic cross-sectional view of a blister of a drug release tape of the present invention.

Figure 6 is a schematic longitudinal cross-sectional view of a blister of a drug release tape of the present invention.

detailed description

The technical solutions in the embodiments of the present invention are clearly and completely described in the following with reference to the accompanying drawings in the embodiments of the present invention. It is obvious that the described embodiments are only a part of the embodiments of the present invention, but not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative efforts are within the scope of the present invention.

1 to 3, a schematic view showing a mounting structure of a drug releasing tape 1 according to the present invention, The drug releasing tape 1 is a blister strip which can be used for releasing a powder or granulated drug, and in particular, a release tape which can be used for inhaling a powdered drug for asthma.

Specifically, FIG. 1 shows a drug releasing device 13 in which the drug releasing tape 1 of the present invention can be installed; FIG. 2 is a schematic view showing the internal structure of the drug releasing device 13 shown in FIG. The partial outer structure of Fig. 1 is removed; Fig. 3 is a schematic view showing the structure of the drug release tape 1 according to a specific embodiment of the present invention.

Referring to Fig. 1, the drug releasing tape 1 of the present invention can be used for mounting in the drug releasing device 13 shown in Fig. 1. The basic principle of the drug releasing device 13 is similar to the prior art, and those skilled in the art can easily pass the background art. The prior art provided provides an understanding of the principles of installation and use of the drug release tape 1 of the present invention and will not be further described herein.

As can be seen from Fig. 2 to Fig. 3, the drug releasing tape 1 of the present invention can be used for quantitative release of a powder or granular drug 10, which is composed of a substrate 11 and a cover sheet 12 which are in close contact with each other, the substrate A plurality of blister 111 is formed on the substrate 10, and the drug 10 is sealed in the blister 111 by the substrate 11 and the cover sheet 12, the substrate 11 and the cover sheet of the release end of the drug release tape 1. 12 is in a separated structure, and the ends of the substrate 11 and the cover sheet 12 which are in a separated structure are wound around the slit 21 of the substrate winding wheel 20 and the cover sheet winding wheel 30, respectively. The substrate 11 and the cover sheet 12 can be gradually separated by the rotation of the substrate winding wheel 20 and the cover sheet winding wheel 30, so that the medicine 10 in the medicine bubble 111 is exposed, so that the exposed medicine 10 can be inhaled by the patient. Inhale the nose, mouth or lungs of the patient.

Different from the prior art, in order to solve the defects of the prior art, a protrusion 112 that can be snapped into the slit 21 is stamped and formed at the end of the substrate 11, which can be used simply. By inserting the projection 112 into the slit 21, it can be easily mounted and it is not easy to introduce contamination during the mounting process. In addition, the protrusions 112 can be processed by a standardized mechanical stamping method, and the results are uniform, which avoids the randomness of the subsequent winding installation. Further, the above-described projections 112 employed in the present invention are more firmly mounted, the ends of the substrate 11 are less likely to be detached from the slits 21, and the winding diameter of the substrate 11 can be greatly reduced by eliminating the process of winding the substrate 11. Increases the effective use length of the drug release tape 1.

According to an embodiment of the present invention, as shown in FIG. 2, the slit 21 of the substrate winding wheel 20 is disposed on the cylindrical hollow rotating shaft 22 of the substrate winding wheel 20, and the size of the protruding portion 112 is larger than the The width of the slit 21 is smaller than the inner diameter of the cylindrical hollow shaft 22, that is, in the present invention, the protrusion 112 protrudes from the surface of the substrate 11 by a height greater than the width of the slit 21 and smaller than the cylindrical hollow shaft 22 Inner diameter. In the present embodiment, by using the cylindrical hollow shaft 22, when the end of the substrate 11 is caught in the slit 21, the protruding portion 112 at the end of the substrate 11 is snapped inside the cylindrical hollow shaft 22 from the slit 21, thereby The fastening of the end of the substrate 11 to the slit 21 is enhanced.

Further, in a state where the protruding portion 112 is caught in the slit 21, the end of the substrate 11 does not protrude from the outer surface of the cylindrical hollow rotating shaft 22. The advantage of this design is that after the substrate 11 is snapped into the cylindrical hollow shaft 22, no additional structure protrudes from the outer surface of the cylindrical hollow shaft 22, thereby further reducing the winding diameter of the substrate 11, which is more advantageous in The use of a longer effective drug release tape 1 in the same spatial range improves the utilization rate of the drug release tape 1.

According to an embodiment of the present invention, as shown in FIGS. 4 to 6, the length L1 of the medicine bubble 111 is 7.26 mm to 7.86 mm, the width L2 of the medicine bubble 111 is 4.06 mm to 5.06 mm, and the height L3 of the medicine bubble 111 is 1.60mm～1.90mm, the present invention reasonably reduces the height L3 of the blister 111 and increases the medicine, compared with the size data of the blister disclosed in the prior art under the premise that the volume of the blister of the prior art remains unchanged. The width L2 of the bubble 111 is such that the depth of the blister 111 is lowered, so that the powder contained in the blister 111 does not easily accumulate in the blister 111 after being inhaled by the patient, and the decrease in the height of the blister 111 increases the drug release. With 1 winding space utilization.

Further, in a specific embodiment of the present invention, the height L3 of the blister 111 may be 1.70 mm to 1.80 mm, and the width L2 of the blister 111 may be 4.26 mm to 4.86 mm. Compared with the above embodiment, the width L2 and the height L3 of the bubble 111 are reduced in range and further optimized.

Further, in the present embodiment, the height L3 of the bubble 111 is 1.75 mm, the width L2 of the bubble 111 is 4.56 mm, and the length L1 of the bubble 111 is 7.56 mm.

According to an embodiment of the present invention, as shown in FIG. 5, the angle α between the tangent to the end of the cross section of the bubble 111 and the mid-perpendicular line of the bubble 111 is 35.3° to 37.3°, preferably The angle α is 36.3°. In this embodiment, the angle α between the tangent to the end of the cross section of the bubble 111 and the mid-perpendicular line is disclosed, and the ratio of the height L3 and the width L2 of the bubble 111 is reasonably limited, thereby effectively reducing the bubble. The powder after inhalation of the patient in 111 remains, and the winding utilization ratio of the substrate 11 having a plurality of blister 111 is increased.

Further, in the present invention, the shape of the protrusion 112 at the end of the substrate 11 is the same as that of the blister 111. Specifically, the blister 111 and the protrusion 112 are substantially semi-circular or curved. . In the present embodiment, since the protrusions 112 and the blister 111 have the same structure, the protrusions 112 can be formed by using the same mold as the stamping blister 111, which reduces the number of processing steps and saves production costs.

The invention adjusts the size of the medicine bubble 111, optimizes the shape of the medicine bubble 111, reduces the height of the medicine bubble 111, makes the patient have lower resistance when inhaling the powder, increases the emptying rate of the medicine bubble 111, and further improves The space utilization in the inhaler increases the effective length of the drug release tape 1. The present invention can reduce the U-shaped airflow resistance generated by the patient's inhalation by a reasonable angle α and the height L3 of the blister 111, so that the drug 10 in the blister 111 can be more easily sucked out by the patient.

In a specific embodiment of the invention, a set of comparative experiments are set forth below:

experimental method

1. Randomly select 3 GlaxoSmithKline produced drug release tapes of the present invention

For the inhaler, take two drug release tapes 1 of the size of this embodiment (length L1 = 7.56 mm; width L2 = 4.56 mm; height L3 = 1.75 mm) to replace the two

Original drug release tape in the inhaler and marked as No. 1 and No. 2, another

The inhaler retains the original drug release tape (length L1 = 7.56mm; width L2 = 3.80mm; height L3 = 2.00mm;) and is marked as No. 3, and the drug release tapes of the above inhalers No. 1, No. 2, No. 3 are loaded. There is a quantitative amount of salmeterol carcassone powder.

2. Randomly take 3 drug release tapes and 3 original drug release tapes of this example, take 10 medicated foams for each strip, weigh them, weigh the powder of each blister, weigh, and calculate the weight of 10 vesicles. Make sure the load is basically the same and calculate the average load.

3. Carry out the emptying rate experiment, take the above-mentioned inhalers labeled No. 1, No. 2, No. 3, and carry out the simulation test with NGI-170 aerosol sampler, set the airflow to 60L/min, and collect 10 bubbles. After weighing, the emptying amount is calculated, and the emptying rate is calculated in comparison with the average loading. A total of 6 x 10 blister data were collected for each set of instruments.

4. The experimental results are shown in Table 1. The emptying rate marked as No. 1 and No. 2 is significantly higher than that of the imported drug release tape labeled No. 3, which effectively reduces the residual rate of the powder and ensures that the patient can obtain a sufficient therapeutic amount. Drugs (Note: W0 is the total weight of the drug before the drug is aspirated, W1 is the total weight of the drug after the drug is aspirated, and the RSD is the relative standard deviation, which is the relative standard deviation).

Table 1 emptying rate experiment results

The drug release tape 1 of the present invention provides a standardized processing protrusion 112 at the end of the substrate 11. The protrusion 112 has a simple structure, a strong buckle, is not easily detached from the slit 21, and is easy to install and difficult to install. Contamination is introduced in the process, and the protrusions 112 do not cause the substrate 11 to be wound in a larger diameter, which increases the effective use length of the drug release tape 1.

The drug releasing tape 1 of the present invention has a medicinal blister 111 having a reasonable size and shape, and has a low airflow resistance when inhaling a drug, so that a patient with respiratory diseases having a low lung capacity is more likely to aspirate the drug; in addition, the height of the blister 111 is lowered. It effectively improves the difficulty of emptying the powder, so that the residual amount of the powder is low, and the patient can obtain a sufficient therapeutic amount of the medicine; finally, the height of the medicine 111 is lowered, and the height of the drug release belt 1 is also lowered, further increasing the drug release belt. 1 The number of turns wound in the powder discharge device, thereby increasing the effective use length of the drug release tape 1.

The above is only a few embodiments of the present invention, and various changes and modifications may be made to the embodiments of the present invention without departing from the spirit and scope of the invention.

Claims

A drug release tape (1) for quantitatively releasing a powder or granular drug (10), which is adhered to a substrate (11) and a cover sheet (12) a plurality of blister (111) formed on the substrate (11), the drug (10) being sealed by the substrate (11) and the cover sheet (12) in the blister ( 111), the substrate (11) and the cover sheet (12) of the release end of the drug release tape (1) have a separated structure, and the substrate (11) has a separated structure. And the end of the cover sheet (12) is wound around the slit (21) of the substrate winding wheel (20) and the cover sheet winding wheel (30), respectively, characterized in that the end of the substrate (11) is stamped. A protrusion (112) that is snapped into the slit (21) is formed.
The drug releasing tape according to claim 1, wherein said blister (111) has a height of 1.60 mm to 1.90 mm, and said blister (111) has a width of 4.06 mm to 5.06 mm. The length of the bubble (111) is 7.26 mm to 7.86 mm.
The drug releasing tape according to claim 2, wherein said blister (111) has a height of 1.75 mm, said blister (111) has a width of 4.56 mm, and said blister (111) has a length. It is 7.56mm.
The drug release tape according to any one of claims 1 to 3, wherein a slit (21) of the substrate winding wheel (20) is provided in a cylindrical shape of the substrate winding wheel (20) On the hollow shaft (22), the protrusion (112) has a size larger than the width of the slit (21) and smaller than the inner diameter of the cylindrical hollow shaft (22).
The drug release tape according to any one of claims 1 to 3, wherein the protrusion (112) has the same structure as the blister (111).
The drug releasing tape according to claim 4, wherein the end of the substrate (11) does not protrude in a state where the protruding portion (112) is caught in the slit (21) The outer surface of the cylindrical hollow shaft (22).
The drug release tape according to any one of claims 1 to 3, wherein a tangent to the end of the cross section of the blister (111) and a midline of the blister (111) The angle is between 35.3 ° and 37.3 °.
The drug release tape according to claim 7, wherein an angle between a tangent to the end of the cross section of the blister (111) and a midline of the blister (111) is 36.3. .