Transdermal patch and preparation method thereof

Abstract

The present invention relates to a method (100) for preparing a transdermal patch (200). The method (100) achieves an accurate dosing of the drug, an accurate dispensing location, and an average distribution of the drug coating in the transdermal patch (200). The method (100) excludes heating and drying steps generally used in conventional transdermal patch preparation methods in order to maintain the quality of the drug in the transdermal patch (200). The invention also relates to said transdermal patch (200) for use in the treatment of wounds or scars, wherein said transdermal patch (200) comprises a backing film (220), a film layer (240) coated with said medicament, an adhesive layer (260) and a release liner (280). Preferably, the drug in the transdermal patch (200) comprises a synthetic formulation or a natural formulation with biological properties, depending on the desired treatment.

Description

Technical Field

[0001] This invention relates to a transdermal patch and a method for preparing the patch. More specifically, this invention relates to a method for preparing a transdermal patch for treatment (including wound and scar treatment). Background Technology

[0002] Transdermal patches are medical devices designed to deliver medications or active ingredients directly to the site of a wound for various treatments, such as wound or scar healing, treatment of inflammation or infection, and pain relief, through skin contact. Typically, the medication can be a natural ingredient, an anti-inflammatory agent, an antibiotic, or other compound to achieve the various desired uses and effects of a transdermal patch. Transdermal patches can be classified into three groups: reservoir patches, matrix patches, and adhesive-coated drug patches. Reservoir transdermal patches generally consist of multiple layers: an adhesive layer that holds the patch to the skin, a liner that covers the adhesive layer before application, a drug reservoir containing the medication or active ingredient, a rate control membrane, and a backing layer that serves as the outermost layer when adhered to the skin. In contrast, adhesive-coated drug patches do not require a rate control membrane or a separate drug reservoir; instead, the medication is infused directly into the adhesive layer. On the other hand, in matrix patches, the medication is dispersed or dissolved within a polymer matrix that forms part of the adhesive layer.

[0003] Transdermal patches can be prepared using various methods. Some common methods include hot melt extrusion, solvent casting, and compression molding. Each method has its advantages, and the choice of method is influenced by various factors such as the properties of the drug, manufacturing capabilities, and resources.

[0004] Despite their benefits, existing transdermal patches face several challenges, such as limited drug types, limited permeability, and adhesion issues. Consistent and controlled drug release can be difficult to achieve, and drug stability within the patch can be problematic. Users may experience skin irritation or allergic reactions due to the materials used (such as adhesives or even the drugs contained in the patch). Furthermore, existing methods for manufacturing transdermal patches have drawbacks, including complex and lengthy manufacturing processes and high production costs. In addition, quality control challenges exist, such as ensuring uniform drug distribution during patch production.

[0005] Several solutions already exist for providing transdermal patches and methods for preparing transdermal patches, and two of them are discussed below:

[0006] CN111346073B discloses a pharmaceutical composition for transdermal application, its preparation method, and its use. This prior art aims to provide a ketamine-containing formulation that is stable for room temperature storage, reducing the production cycle and cost of the formulation, minimizing side effects and frequency of application, and promoting patient administration and self-management. The composition consists of a compound represented by formula (I) containing ketamine or other pharmaceutically acceptable salts, a polymer dispersion carrier material, a heat-melting protectant, and optionally a melt agent. A method for preparing a transdermal patch includes the following steps: a) preparing microparticles of a compound represented by formula (I) or its pharmaceutically acceptable salts into alcohol liposomes, and stirring and dissolving the alcohol liposomes, a transdermal absorption enhancer, and an antioxidant; b) mixing with a pressure-sensitive adhesive and then with a polymer backbone carrier material; and c) drying to remove low-molecular-weight organic alcohols from the alcohol liposomes, coating them onto an anti-adhesion layer, and covering them with a backing layer. Preferably, the micronization at step a) includes hot-melt extrusion at a temperature between 100°C and 180°C before preparing the obtained particles into alcohol liposomes. The content of the compound represented by formula (I) or the pharmaceutically acceptable salt is 1 to 300 mg / patch, more preferably 5 to 120 mg / patch.

[0007] US2021030694A1 discloses a transdermal drug delivery patch for long-wear dermal delivery patches that causes less irritation and less detachment over a seven-day period, and a method for preparing the patch. The patch comprises: a) a polymer matrix active ingredient (AI) layer having a skin contact surface and a non-skin contact surface and containing a pressure-sensitive adhesive (PSA) and a volatile component at least partially dissolved in the PSA; b) a release liner in direct contact with the skin contact surface of the AI ​​layer; c) an overlay comprising (i) the PSA layer and (ii) an overlay covering adjacent to the non-skin contact surface of the AI ​​layer; and d) an inner backing layer located between the non-skin contact surface of the AI ​​layer and the PSA layer of the overlay. Preferably, a moisturizer is incorporated into the polymer matrix of the AI ​​layer to reduce irritation and enhance adhesion. On the other hand, the method includes the following steps: (1) manufacturing an inner backing / AI layer / release liner laminate by applying an AI layer to one of a release liner or an inner backing layer, drying the AI ​​layer at a set temperature for a set time, and then applying the other of the inner backing layer or release liner to the AI ​​layer; and subsequently (2) manufacturing a drug delivery device by laminating the laminate to the inner backing layer side of the inner backing / AI layer / release liner laminate.

[0008] However, the methods disclosed in the prior art are still lengthy and costly. Furthermore, none of the prior art discloses steps for ensuring the average amount and distribution of the active ingredient during the preparation process.

[0009] Therefore, it is evident from the existing technology that there is a need for more efficient methods for preparing transdermal patches. There is also a need to improve the quality of transdermal patches, avoid potential damage to the formulations within the transdermal patch, and reduce production time. Summary of the Invention

[0010] The following is a simplified summary of the invention to provide a basic understanding of some aspects of it. This summary is not a broad overview of the invention. Its sole purpose is to present some of the concepts of the invention in a simplified form as a prelude to the more detailed description that follows.

[0011] The purpose of this invention is to provide a method for preparing transdermal patches with simplified steps, reduced equipment investment, and reduced production time.

[0012] Another object of the present invention is to provide a method for preparing transdermal patches without the heating and drying steps typically used in conventional transdermal patch preparation methods.

[0013] Furthermore, the purpose of this invention is to provide a method for preparing transdermal patches that achieves precise dosage, accurate application location, uniform drug coating, and maintains the quality of the drug in the patch.

[0014] Another object of the present invention is to prepare transdermal patches with improved quality for various treatments, including wound and scar treatment.

[0015] Therefore, these objectives can be achieved by following the teachings of this invention.

[0016] This invention relates to a method for preparing a transdermal patch, the method comprising the following steps: preparing a semi-finished product, including: i. preparing an adhesive layer by hot melt extrusion; ii. simultaneously coating the adhesive layer onto a film layer; and attaching a release liner to the adhesive layer to obtain the semi-finished product; applying a drug coating to the semi-finished product; sealing the drug-coated semi-finished product with a backing film to obtain a laminate; and cutting the laminate to a desired size and packaging the cut laminates to obtain individual transdermal patches; wherein the drug coating is applied to the semi-finished product using a dispensing system to achieve precise dosage and dispensing position; and wherein the drug coating is applied to the semi-finished product within a set temperature range without the need for an additional heating step to maintain the moisture content of the drug.

[0017] According to an embodiment of the present invention, the precise dosage and dispensing location of the drug coating are calculated by the dispensing system using artificial intelligence.

[0018] According to embodiments of the present invention, the temperature range for applying the drug coating is between 20°C and 29°C, but is not limited thereto.

[0019] According to an embodiment of the present invention, the drug is a matrix having a formulation mixed with excipients.

[0020] According to embodiments of the present invention, the formulations include, but are not limited to, synthetic formulations or natural formulations with biological properties.

[0021] According to embodiments of the present invention, the medicated coating is configured for, but not limited to, wound or scar treatment.

[0022] According to an embodiment of the present invention, the thickness of the thin film layer is, but not limited to, 0.28 to 0.5 mm.

[0023] According to an embodiment of the present invention, the thin film layer is preferably a polylactic acid thin film.

[0024] According to an embodiment of the invention, the adhesive layer is a melt adhesive gel obtained by hot melt extrusion at a temperature between, but not limited to, 140°C and 160°C.

[0025] According to an embodiment of the present invention, the release liner is preferably a silicone paper liner.

[0026] According to an embodiment of the present invention, the backing film is preferably a polylactic acid-based film.

[0027] Additionally, the present invention relates to a transdermal patch for the treatment of wounds or scars, the transdermal patch comprising: a backing film as an uppermost layer; a film layer sealed by the backing film; an adhesive layer coated onto the film layer; and a release liner attached to the adhesive layer; wherein the film layer is coated with a drug; and wherein the drug is a matrix comprising a synthetic formulation mixed with excipients or a natural plant formulation having biological properties.

[0028] According to an embodiment of the present invention, the thin film layer is preferably a polylactic acid thin film.

[0029] According to embodiments of the present invention, the adhesive layer is preferably a non-irritating adhesive.

[0030] According to an embodiment of the present invention, the backing film is preferably a polylactic acid-based film.

[0031] According to an embodiment of the present invention, the release liner is preferably a silicone paper liner.

[0032] The above and other objects, features, aspects and advantages of the invention will be better understood by carefully reading the detailed description provided below with appropriate reference to the accompanying drawings. Attached Figure Description

[0033] To gain a detailed understanding of the above-described features of the invention, a more specific description of the invention, briefly summarized above, can be referenced through embodiments, some of which are illustrated in the accompanying drawings. However, it should be noted that the drawings illustrate only typical embodiments of the invention and should not be construed as limiting its scope, as other equally effective embodiments are permissible.

[0034] These and other features, benefits, and advantages of the invention will become apparent from the following drawings, in which similar reference numerals denote similar structures, in which:

[0035] Figure 1 This is a flowchart illustrating a method for preparing a transdermal patch according to a preferred embodiment of the present invention.

[0036] Figure 2 This is a schematic diagram of a transdermal patch according to a preferred embodiment of the present invention. Detailed Implementation

[0037] While this invention is described by way of example using embodiments and illustrative drawings, those skilled in the art will recognize that the invention is not limited to the embodiments of the one or more drawings described, and is not intended to represent proportions of the various components. Furthermore, for ease of illustration, some components that may form part of the invention may not be shown in some drawings, and such omissions do not limit the outlined embodiments in any way. It should be understood that the drawings and their detailed description are not intended to limit the invention to the specific forms disclosed; rather, the invention covers all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims. As used throughout this specification, the word “may” is used in a permissible sense (i.e., meaning possible) rather than a mandatory sense (i.e., meaning must). Furthermore, unless otherwise mentioned, the words “a” or “an” mean “at least one,” and the words “a plurality of” mean “one or more.” Moreover, the terminology and wording used herein are for descriptive purposes only and should not be construed as limiting in scope. Language such as “comprising,” “including,” “having,” “containing,” or “involving,” and variations thereof, is intended to be broad and encompass the subject matter listed thereafter, equivalents, and additional subject matter not elaborated, and is not intended to exclude other additions, components, integrals, or steps. Similarly, for the purposes of applicable law, the term “comprising” is considered synonymous with the terms “including” or “containing.” Any discussion of documents, actions, materials, devices, articles, etc., is included in the specification and is intended solely to provide background information for the invention. No implication or representation is made that any or all of these contents form part of the prior art or are common general knowledge in the field related to the invention.

[0038] In this patent specification, whenever a composition, element, or group of elements is preceded by the transitional phrase “comprising”, it should be understood that we also envision the same composition, element, or group of elements preceded by the transitional phrases “composed of,” “consisting of,” “selected from the group of,” “comprising,” or “is,” and vice versa.

[0039] The invention is described below with reference to the accompanying drawings, which use reference numerals throughout the specification to correspond to similar elements. However, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. In the following detailed description, numerical values ​​and ranges are provided for various aspects of the described implementations. These values ​​and ranges are considered exemplary only and are not intended to limit the scope of the claims. Furthermore, numerous materials are considered suitable for various aspects of the implementations. These materials are considered illustrative only and are not intended to limit the scope of the invention.

[0040] This invention relates to a method for preparing a transdermal patch. This method achieves precise drug dosing, accurate application site, and uniform distribution of the drug coating within the transdermal patch. This method eliminates the heating and drying steps typically used in conventional transdermal patch preparation methods to maintain the quality of the drug in the transdermal patch. The invention also relates to a transdermal patch for the treatment of wounds or scars, wherein the transdermal patch comprises a backing film, a drug-coated film layer, an adhesive layer, and a release liner. Preferably, depending on the desired treatment, the drug in the transdermal patch comprises a synthetic formulation or a naturally occurring formulation with biological properties.

[0041] For reference Figure 1 and 2 The invention will now be described in more detail, based on the accompanying drawings.

[0042] Figure 1This is a flowchart illustrating a method (100) for preparing a transdermal patch (200) according to a preferred embodiment of the present invention. The method (100) begins with a step (S120) of preparing a semi-finished product. More specifically, the semi-finished product is prepared by: firstly (S120a) preparing an adhesive layer (260) by hot melt extrusion, then (S120b) simultaneously coating the adhesive layer (260) onto a film layer (240), and then (S120c) attaching a release liner (280) to the adhesive layer (260) to obtain the semi-finished product. Preferably, the film layer (240) is used in the preparation method (100) to provide support for the transdermal patch (200). More preferably, depending on the desired transdermal patch, the film layer (240) is made of a biodegradable or non-biodegradable material. The semi-finished product is then rolled up for use in the next step of the process.

[0043] As in step S120a, an adhesive layer (260) is prepared by melting the adhesive. This adhesive preferably meets the standards set by the U.S. Food and Drug Administration (FDA) to ensure safety in direct skin contact. Furthermore, the prepared adhesive layer (260) is preferably a non-irritating adhesive. More specifically, the prepared adhesive layer (260) is a non-irritating FDA-grade adhesive.

[0044] According to an embodiment of the invention, the adhesive layer (260) is a melt adhesive gel obtained by hot melt extrusion at a temperature between, but not limited to, 140°C and 160°C.

[0045] According to an embodiment of the present invention, the thin film layer (240) has a thickness of, but not limited to, 0.28 to 0.5 mm.

[0046] According to an embodiment of the present invention, the thin film layer (240) is preferably a polylactic acid (PLA) film.

[0047] According to an embodiment of the present invention, the release liner (280) is preferably a silicone paper liner.

[0048] Following method (100) is (S140) the drug coating is applied to the semi-finished product. The drug preferably comprises a natural or synthetic formulation, wherein the choice of drug depends on the desired treatment. More specifically, the drug coating is applied to the semi-finished product using a dispensing system (S140) to achieve precise dosage and dispensing location. Specifically, the dispensing system is an intelligent precision dispensing system that precisely determines the optimal dosage of the drug and the required dispensing location, and precisely controls the application of the drug coating (S140).

[0049] According to an embodiment of the present invention, the precise dosage and dispensing location of the drug coating are calculated by the dispensing system using artificial intelligence (AI).

[0050] According to an embodiment of the present invention, the drug is a matrix having a formulation mixed with excipients.

[0051] According to embodiments of the present invention, the formulations include, but are not limited to, synthetic formulations or natural plant formulations with biological properties.

[0052] According to embodiments of the present invention, the medicated coating is configured for, but not limited to, wound or scar treatment.

[0053] Furthermore, the drug coating is applied to the semi-finished product within a set temperature range (S140) without the need for additional heating steps to maintain the moisture content of the drug. Therefore, the drug coating step (S140) included in method (100) does not employ the conventional heating and oven drying steps used in existing transdermal patch preparation methods.

[0054] According to an embodiment of the present invention, the temperature range for applying (S140) the drug coating is between 20°C and 29°C, but is not limited thereto.

[0055] However, method (100) is also configured to allow heating to a certain extent during the application of the drug coating (S140) if heating is required to achieve the desired effect. There is no set temperature range for heating, and it depends on the freezing and boiling points of the formulation in the drug.

[0056] like Figure 1 As shown, method (100) continues (S160) by sealing the drug-coated semi-finished product with a backing film (220) to obtain a laminate. The backing film (220) is preferably an impermeable backing film. Specifically, the laminate is a single large patch. Finally, method (100) ends (S180) by cutting the laminate to the desired size and packaging the cut laminate to obtain individual transdermal patches (200). Furthermore, the patch (200) prepared by method (100) is preferably a transdermal patch or a hydrocolloid patch.

[0057] According to an embodiment of the present invention, the backing film (220) is preferably a PLA-based film.

[0058] In general, method (100) is configured to prepare a transdermal patch (200) having a skin-compatible design and materials. More specifically, method (100) is configured to prepare a transdermal patch (200) having an optimal drug release rate and duration by using an application system.

[0059] Figure 2This is a schematic diagram of a transdermal patch (200) according to a preferred embodiment of the present invention. More specifically, the transdermal patch (200) for wound or scar treatment comprises four main layers: a backing film (220), a film layer (240), an adhesive layer (260), and a release liner (280). Preferably, the adhesive layer (260) is obtained by hot melt extrusion prior to being coated onto the film layer (240). More preferably, the adhesive layer (260) meets the standards set by the U.S. Food and Drug Administration (FDA) to ensure safety in direct contact with the skin. On the other hand, depending on the desired transdermal patch, the film layer (240) is preferably made of a biodegradable or non-biodegradable material. In addition, the film layer (240) coated with the adhesive layer (260) is further coated with a drug. Preferably, the drug is a matrix comprising a synthetic formulation mixed with excipients or a natural plant formulation having biological properties.

[0060] According to an embodiment of the present invention, the thin film layer (240) is preferably a PLA thin film.

[0061] According to an embodiment of the invention, the adhesive layer (260) is preferably a non-irritating adhesive. Further, the non-irritating adhesive is an FDA-grade adhesive.

[0062] like Figure 2 As shown, a release liner (280) is attached to the adhesive layer (260) of the patch (200). The release liner (280) is configured to cover and protect the adhesive layer (260) before use. Specifically, the release liner (280) is removed before application to the skin. More specifically, the combination of the release liner (280), the adhesive layer (260), and the film layer (240) forms a semi-finished product. On the other hand, the film layer (240) is sealed by a backing film (220). Preferably, the backing film (220) is the uppermost layer of the transdermal patch (200). More preferably, the backing film (220) is configured as a barrier to protect all other layers (240, 260, 280) in the transdermal patch (200) and to provide structural support when the transdermal patch (200) is used on the skin.

[0063] According to an embodiment of the present invention, the backing film (220) is preferably a PLA-based film.

[0064] According to an embodiment of the present invention, the release liner (280) is preferably a silicone paper liner.

[0065] In summary, this method (100) has the following advantages over existing methods:

[0066] 1) Utilizing an AI-driven dispensing system, it accurately determines the dosage, dispensing location, and controls the flow rate for dispensing the drug coating onto the thin film layer;

[0067] 2) Eliminates the heating and oven drying steps during drug coating (S140) typically used in conventional patch preparation processes, thereby retaining moisture and preventing potential damage to the formulation in the drug;

[0068] 3) Shorten the overall process cycle time; and

[0069] 4) Producing patches, including transdermal patches and hydrocolloid patches, for a variety of treatments, including wound or scar treatment.

[0070] The illustrative implementations described above are illustrated using specific shapes, sizes, and other characteristics; however, the scope of the invention also includes various other shapes, sizes, and characteristics. Furthermore, the components described above can be manufactured in various other ways and can comprise various other materials.

[0071] Various modifications to these embodiments will be apparent to those skilled in the art from the description and accompanying drawings. The principles associated with the various embodiments described herein can be applied to other embodiments. Therefore, the description is not intended to be limited to the embodiments shown in conjunction with the drawings, but is intended to provide the widest scope consistent with the principles disclosed or suggested herein, as well as the novelty and inventiveness features. Accordingly, the invention is intended to reserve all other such alternatives, modifications, and variations falling within the scope of the invention and the appended claims.

[0072] Although the invention has been described with reference to specific embodiments and shown in the accompanying drawings, it will be apparent to those skilled in the art that many variations and modifications can be made within the scope of the invention, as described in the specification and defined in the following claims.

[0073] Description of reference numerals used in the accompanying drawings according to the present invention:

[0074]

[0075]

Claims

1. A method (100) for preparing a transdermal patch, the method (100) comprising the following steps: (S120) Prepare a semi-finished product, including: i. (S120a) The adhesive layer (260) is prepared by hot melt extrusion; ii. (S120b) Simultaneously, the adhesive layer (260) is coated onto the film layer (240); and iii. (S120c) Attach the release liner (280) to the adhesive layer (260) to obtain the semi-finished product; (S140) Apply the drug coating to the semi-finished product; (S160) Seal the drug-coated semi-finished product with a backing film (220) to obtain a laminate; and (S180) The laminate is cut to the desired size and the cut laminate is packaged to obtain individual transdermal patches (200); The drug coating is applied to the semi-finished product using a dispensing system (S140) to achieve precise dosage and dispensing location; and The drug coating is applied to the semi-finished product within a set temperature range (S140) without additional heating steps to maintain the moisture content of the drug.

2. The method (100) according to claim 1, wherein the precise dosage and dispensing position of the drug coating (S140) is calculated by the dispensing system using artificial intelligence.

3. The method (100) according to claim 1, wherein the temperature range for applying (S140) the drug coating is between 20°C and 29°C.

4. The method (100) according to claim 1, wherein the drug is a matrix having a formulation mixed with excipients.

5. The method (100) according to claim 4, wherein the formulation comprises a synthetic formulation or a natural plant formulation having biological properties.

6. The method (100) according to claim 1, wherein the drug coating (S140) is configured for wound or scar treatment.

7. The method (100) according to claim 1, wherein the thin film layer (240) has a thickness of 0.28 to 0.5 mm.

8. The method (100) according to claim 1, wherein the thin film layer (240) comprises a polylactic acid film.

9. The method (100) according to claim 1, wherein the adhesive layer (260) is a melt adhesive gel obtained by hot melt extrusion at a temperature between 140°C and 160°C.

10. The method (100) according to claim 1, wherein the release liner (280) is a silicone paper liner.

11. The method (100) according to claim 1, wherein the backing film (220) is a polylactic acid-based film.

12. A transdermal patch (200) for treating wounds or scars, said transdermal patch (200) comprising: As the topmost backing film (220); A film layer (240) sealed by the backing film (220); An adhesive layer (260) coated on the thin film layer (240); and Release liner (280) attached to the adhesive layer (260); The thin film layer (240) is coated with a drug; and The drug is a matrix comprising a synthetic formulation mixed with excipients or a natural plant formulation having biological properties.

13. The transdermal patch (200) according to claim 11, wherein the film layer (240) comprises a polylactic acid film.

14. The transdermal patch (200) according to claim 11, wherein the adhesive layer (260) is a non-irritating adhesive.

15. The transdermal patch (200) according to claim 11, wherein the backing film (220) is a polylactic acid film.

16. The transdermal patch (200) according to claim 11, wherein the release liner (280) is a silicone paper liner.

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