Haemostatic agent formulation

Abstract

Novel Haemostatic Agent Formulation is meticulously crafted for two distinct applications: convenient hemostatic spray and integration with protective armor fabric. The preparation process involves the careful combination of key ingredients, including Sodium Polyacrylamide (1), Vitamin K2 (12), Propylene Glycol (3), Glycerine (4), and Ethanol (2) as the primary solvent. Ethyl cellulose (7) and Hydroxypropyl cellulose (5) are added for stability and viscosity control, while Polyvinylpyrrolidone (PVP) (6) enhances binding. Colloidal silicon dioxide (8), Talc (9), Magnesium Stearate (10), and Alum (11) are included for their absorbent properties. The formulation is optimized for consistency and dispersion, with pH adjustment as needed. The hemostatic agent is then utilized for spray containers with LPG propellant or integrated into armor fabric through controlled application methods, offering hemostatic protection for wounds. This versatile formulation showcases the potential for tailored interventions in emergency wound management, providing a life-saving solution with enhanced efficacy and improved patient outcomes.

Description

[0001] Title of Invention

[0002] Haemostatic Agent Formulation

[0003] Field of Invention

[0004] The present invention relates to the field of haemostatic formulations and, more particularly, to a novel haemostatic formulation for the control of bleeding with two potential applications, one is spray formulation and another is integration with fabric that can be further used in armor.

[0005] Background of Invention

[0006] In emergency medical situations, particularly those involving traumatic injuries, haemorrhage control is of paramount importance. Uncontrolled bleeding can rapidly lead to shock, organ failure, and, if left untreated, death may cause. Effective haemostatic materials and techniques are, therefore, essential to addressing this critical aspect of trauma care.

[0007] Effective haemostatic materials and techniques are, therefore, essential in addressing this critical aspect of trauma care. Traditional methods, such as gauze, pressure dressings, and tourniquets, have been used for centuries and are widely available. While these methods can be effective for minor to moderate bleeding, they may not suffice in severe cases, especially when internal organs or large blood vessels are involved. Additionally, they require constant pressure and monitoring, which can be challenging in emergency situations. In recent decades, advanced haemostatic products have been developed to address these limitations. These include absorbent pads, haemostatic gels, and sealants, which aim to improve wound i sealing and promote clotting. However, existing haemostatic solutions still have their challenges. The efficiency of traditional methods diminishes in severe bleeding scenarios, calling for more advanced interventions. Speed of action is also a critical factor, as many haemostatic materials rely on natural clotting processes that may be too slow in emergencies. Furthermore, cost can be a significant barrier, with advanced haemostatic products often being expensive and inaccessible in low-resource settings.

[0008] An invention disclosed in patent application number US9265858B2 discloses a dry composition, which upon addition of an aqueous medium forms a substantially homogenous paste suitable for use in haemostasis procedures. The paste forms spontaneously upon addition of the liquid, hence no mechanical mixing is required for said paste to form. Further disclosed are methods of preparing said dry composition, a paste made from said dry composition and use of said paste for medical and surgical purposes.

[0009] An invention disclosed in patent application number US10159762B2 discloses haemostatic compositions comprising components of the flowers of pharmaceutical chamomile (Chamomilla recutita), the leaves of dioecious nettle (Urtica dioica), kaolin, chitosan, fibrinogen and thrombin. Further inclusion of a biocompatible polymeric base, particularly an alignate, generates a composition with superior and broad-spectrum haemostatic capabilities, including the ability to arrest arterial haemorrhage. The invention further provides methods of using the inventive compositions in to reduce or stop bleeding, as well as a variety of apparatuses useful in haemostatic contexts that incorporate the inventive compositions. In one particular embodiment, the invention provides haemostatic dressings in which a polymeric layer incorporating chamomile, nettle, kaolin, chitosan, fibrinogen and thrombin components is applied to a textile or fabric material, for example a non-woven viscose. Certain haemostatic agents have also been associated with adverse reactions, including inflammation and tissue damage, which can hinder the healing process. To address these limitations, The present invention offers a groundbreaking solution to address these limitations by introducing a novel haemostatic formulation. This formulation is designed to be highly effective, acting rapidly to control bleeding, and easy to use, ensuring efficiency in emergency situations. Additionally, making it accessible to a wider range of medical settings.

[0010] The present invention introduces a groundbreaking approach to control bleeding with a novel hemostatic formulation delivered through a unique spray format and integration with fabric to be further used in Armor. The present novel invention intersects with three critical domains in medical advancement: hemostatic agents, drug delivery systems, and wound management practices, offering a comprehensive solution for hemorrhage control.

[0011] Firstly, within the realm of hemostatic agents, present invention introduces a novel spraybased formulation that sets itself apart from traditional methods. The spray format provides a practical and efficient way to manage bleeding, making it a quick and easy solution for trauma care.

[0012] One of the key advantages of our invention is its specialized drug delivery system. This system is meticulously designed for the hemostatic formulation, ensuring precise and targeted application. By optimizing the delivery mechanism, the effectiveness of the hemostatic agent is maximized, leading to swift and controlled bleeding management.

[0013] Secondly, the invention significantly contributes to wound management practices. The novel formulation is versatile and effective for various wound types, providing a much-needed solution in emergency situations. Whether it's a deep laceration or a broad abrasion, the spray-based format offers a convenient and efficient way to manage bleeding, improving patient outcomes.

[0014] Furthermore, one of the potential applications of this novel hemostatic formulation is its integration into fabrics to create advanced armor. By infusing the formulation into the fabric fibers, any lacerations sustained by the wearer will immediately be treated, reducing blood loss and increasing the chances of recovery.

[0015] The invention's uniqueness lies in its ability to synergistically combine these three subfields. By revolutionizing the way bleeding is managed with a novel hemostatic agent, an innovative delivery system, and versatile wound management capabilities, present novel invention offers a comprehensive approach to hemorrhage control, ultimately enhancing patient care in emergency medical situations.

[0016] Objectives of Invention

[0017] • Principal objective of the present novel invention is to provide a novel hemostatic formulation with two distinct and innovative applications, offering a rapid and effective solution for hemorrhage control in emergency situations.

[0018] • Another objective of the present novel invention is to provide a spray-based formulation that revolutionizes the way traumatic injuries are managed. With its unique spray delivery system, the invention ensures easy and precise administration, even in hard-to-reach areas which empowers not just medical professionals but also bystanders to take swift action during critical moments. • Another objective of the present novel invention is to provide integration with fabric used in armor. By infusing the hemostatic formulation into the fabric, it provides continuous and proactive hemostatic protection which ensures that any lacerations or wounds sustained are immediately treated, even before traditional hemostatic methods can be applied and the treated fabric, through controlled application methods such as spraying, dip coating, or weaving, becomes a proactive layer of protection, enhancing the overall effectiveness of the armor.

[0019] • Another objective of the present novel invention is to provide a formulation that design to act swiftly upon contact with the wound, initiating rapid clotting and sealing the injury to prevent further blood loss.

[0020] • Another objective of the present novel invention is to provide versatility as it aims to be adaptable to various traumatic injury scenarios, whether external or internal bleeding, the spray-based delivery system can reach and treat different wound types, ensuring versatility and broad applicability.

[0021] • Another objective of the present novel invention is to provide a formulation that is biocompatible and non-toxic.

[0022] • Another objective of the present novel invention is to provide a highly effective, safe, and accessible solution as it strives to become a go-to tool in emergency medicine, improving patient outcomes and saving lives worldwide.

[0023] Summary

[0024] The present invention introduces a ground-breaking novel hemostatic formulation with two distinct and innovative applications, offering a comprehensive approach to hemorrhage control and wound management. Firstly, it revolutionizes the field of hemostatic agents with a unique spray-based delivery method, providing a practical and efficient solution. This specialized spray delivery system ensures precise and targeted application, enhancing the effectiveness of the hemostatic agent. The invention intersects three critical subfields: hemostatic agents, drug delivery systems, and wound management, offering a synergistic approach to trauma care.

[0025] One of the key applications of the present novel formulation is its use as a hemostatic spray, providing a convenient and portable solution for emergency situations. The spray format allows for easy and rapid application, making it ideal for first responders, military personnel, and trauma care settings. With its unique delivery system, the hemostatic agent can be swiftly applied to control bleeding and improve patient outcomes.

[0026] Secondly, the invention showcases its versatility with the integration of the hemostatic agent into fabric used in armor. By infusing the formulation into the fabric, it provides continuous hemostatic protection to potential wound areas. This application ensures that any lacerations or injuries sustained are immediately treated, reducing blood loss and enhancing the chances of recovery. The treatment of the fabric can be done through controlled methods such as spraying, dip coating, or weaving, ensuring even coverage and effectiveness.

[0027] List of Components

[0028] 1. Sodium Polyacrylamide

[0029] 2. Ethanol

[0030] 3. Propylene Glycol 4. Glycerine

[0031] 5. Hydroxypropyl cellulose

[0032] 6. Polyvinylpyrrolidone (PVP)

[0033] 7. Ethyl Cellulose

[0034] 8. Colloidal Silicon Dioxide

[0035] 9. Talc

[0036] 10. Magnesium Stearate

[0037] 11. Alum

[0038] 12. Vitamin K2

[0039] List of Drawings

[0040] Figure 1: Flowchart

[0041] Table 1: Composition of Novel Haemostatic Agent Formulation

[0042] Table 2: Evaluation Parameters - Batch 1

[0043] Table 3: Evaluation Parameters - Batch 2

[0044] Table 4: Evaluation Parameters - Batch 3

[0045] Table 5: Evaluation Parameters - Batch 4 Detailed Description of Invention

[0046] Materials and Equipment:

[0047] • Sodium Polyacrylamide (1): Hydrophilic polymer with blood-absorbing properties.

[0048] • Ethanol (2): Solvent and preservative.

[0049] • Propylene Glycol (3): Humectant and viscosity modifier.

[0050] • Glycerin (4): Humectant and skin-hydrating agent.

[0051] • Hydroxypropyl cellulose (5): Thickening and binding agent.

[0052] • Polyvinylpyrrolidone (PVP) (6): Binding and dispersing agent.

[0053] • Ethyl Cellulose (7): Thickening agent and film-forming agent.

[0054] • Colloidal Silicon Dioxide (8): act as a glidant, flow agent, and adsorbent.

[0055] • Talc (9): Mineral-based absorbent and carrier.

[0056] • MAG.STE (10): Magnesium Stearate, used as a lubricant and flow agent.

[0057] • Alum (11): Astringent and antimicrobial agent.

[0058] • Vitamin K2 (12): Essential vitamin with blood-cloting abilities.

[0059] • Mortar and pestle or pharmaceutical grinder.

[0060] • #100 mesh sieve.

[0061] • Stirring equipment (glass rod, mechanical stirrer).

[0062] • Analytical balance.

[0063] • Beaker and other glassware.

[0064] • pH meter and calibration solutions.

[0065] • Sterile filter (optional).

[0066] Airtight and labelled storage containers. Process:

[0067] Preparation of Base Solution (101):

[0068] • Ensure that all ingredients are at room temperature before starting.

[0069] • Pre-weigh moisture-sensitive ingredients, such as Vitamin K2 (12), in a desiccator to protect them from humidity.

[0070] • In a clean beaker, slowly introduce Propylene Glycol (3) in the range of 1-2 %W / W, and Glycerine (4) in the range of 1-2%W / W to Ethanol (98.5-99%) (2) in the range of 50- 80%W / W, stirring continuously with a glass rod. Also, add Ethyl cellulose (7) in the range of 0.5-1.5%W / W to this mixture. Mix until you achieve a clear and homogeneous solution.

[0071] Incorporation of Thickening and Binding Agents (102):

[0072] • Set the mechanical stirrer speed to within the range of 700-1000 RPM.

[0073] • Gradually introduce Hydroxypropyl cellulose (5) in the range of 2-4%W / W into the continuously stirred solution to ensure proper dispersion and prevent lump formation.

[0074] • Scrape the sides of the beaker periodically to ensure the efficient incorporation of Hydroxypropyl cellulose (5) into the mixture.

[0075] • Continue stirring until you achieve a uniform and smooth consistency.

[0076] • Add the pre-weighed Polyvinylpyrrolidone (PVP) (6) in the range of 3-20 %W / W while maintaining stirring for complete dispersion.

[0077] Preparation and Addition of Hemostatic Agent (103):

[0078] • Using a mortar and pestle or a pharmaceutical grinder, carefully triturate Sodium Polyacrylamide (1) in the range of 5-80 %W / W to obtain a fine powder. • Pass the triturated powder through a #100 mesh sieve to ensure a uniform particle size distribution.

[0079] • Slowly add the sieved Hemostatic Agent Powder (Sodium Polyacrylamide (1)) to the stirred solution, maintaining continuous mixing to prevent clumping.

[0080] Incorporation of Additional Ingredients (104):

[0081] • Weigh and introduce Colloidal silicon dioxide (8) in the range of 0.5-2 %W / W as a glidant into the mixture, along with Talc (9) in the range of 1-2 %W / W, MAG.STE (10), Alum (11) in the range of 1-2 %W / W, and Vitamin K2 (12) (0.0024 %W / W). Stir continuously to ensure thorough dispersion of all ingredients.

[0082] Evaluation and Adjustment (105):

[0083] • Withdraw a small sample of the prepared formulation for pH measurement.

[0084] • Measure the pH using a calibrated pH meter, ensuring the sample is at room temperature for accurate results.

[0085] • Compare the measured pH to the target range specified and make adjustments as needed using small amounts of dilute acid or base solutions per standard procedures.

[0086] Optional Sterile Filtration (106):

[0087] • Depending on specific requirements, the mixture optionally pass through a sterile filter to eliminate potential contaminants or undispersed particles.

[0088] Storage and Stability Testing (107):

[0089] • Transfer the formulated hemostatic agent into pre-sterilized and labelled airtight storage containers. • Ensure that the storage containers meet the designated specifications for temperature and light exposure requirements.

[0090] Potential Applications (108):

[0091] Hemostatic Spray Formulation:

[0092] The hemostatic agent can be filled into compatible spray containers designed for LPG propellant.

[0093] The LPG gas and the novel hemostatic formulation should be mixed in a 1:1 ratio.

[0094] Use a certified gas filling machine to fill the formulation into the containers, adhering to safety protocols.

[0095] Integration with Armor Fabric:

[0096] The hemostatic agent can be incorporated into the fabric used in armor to provide hemostatic protection.

[0097] Treat the fabric with the hemostatic agent through controlled application methods, such as spraying, dip coating or weaving.

[0098] Ensure the fabric is evenly coated and allow it to dry completely.

[0099] Test the treated fabric for hemostatic efficacy, flexibility, and durability.

[0100] Integrate the treated fabric into the armor design, ensuring it covers potential wound areas.

[0101] Unique two-layer design to maximize comfort and absorbency while keeping the novel powder composition safe and effective. The first layer, made of cotton, is in direct contact with the body, absorbing sweat and providing a comfortable and soft feel. The second layer, a clever combination of synthetic material and a novel powder / crystal composition, is designed with gaps filled with cotton.

[0102] This dual-layer system ensures that while the cotton layer absorbs sweat, it does not penetrate the synthetic layer, keeping the novel powder composition safe and dry even during perspiration. This innovative design is fixable and strategically covers areas like the chest, back, neck, shoulders, and thighs, providing targeted protection and comfort.

[0103] The present novel hemostatic agent can be formulated, and its applications can be tailored for specific purposes, such as a convenient spray formulation or integration with fabric in armor for continuous protection. The versatility of the formulation allows for a range of potential uses, all contributing to effective wound management and improved outcomes.

Claims

Claims,I claim,1. A method for preparing a Haemostatic Agent Formulation, comprising:Preparation of a Base Solution (101); Incorporation of a Thickening and Binding Agents (102);Preparation and Addition of a Hemostatic Agent (103);Incorporation of an Additional Ingredients (104);Evaluation and Adjustment (105);Optional Sterile Filtration (106); Storage and Stability Testing (107); andPotential Applications (108);Wherein preparing the said base solution by mixing a Propylene Glycol (3), a Glycerine (4), an Ethanol (2), and an Ethyl cellulose (7) within specified ranges while stirring continuously for homogeneous solution; Wherein incorporating a Hydroxypropyl cellulose (5) and aPolyvinylpyrrolidone (6) into the said base solution (101) through a controlled mixing process that includes setting a mechanical stirrer speed within a specified range and periodically scraping sides of a mixing vessel;Wherein preparing the said hemostatic agent (103) by triturating a Sodium Polyacrylamide (1) to obtain a fine powder and passing the said powder through a #100 mesh sieve, and then adding the said sieved hemostatic agent powder to the said stirred base solution (101) while maintaining continuous mixing;Wherein incorporating additional ingredients including one or more from a Colloidal silicon dioxide (8), a Talc (9), a Magnesium Stearate (10), an Alum (11), and a Vitamin K2 (12) into the mixture through continuous stirring for thorough dispersion;Wherein further evaluating and adjusting the said formulation by measuring pH and making adjustments as needed;Wherein further optionally performing sterile filtration to eliminate contaminants or undispersed particles;Wherein further storing the said formulated hemostatic agent in pre-sterilized and labeled airtight containers;Wherein further providing potential applications of the said hemostatic agent, including as a hemostatic spray formulation and as an integration with fabric used in the armor, andWherein the said hemostatic agent is applied through controlled methods such as spraying, dip coating, or weaving to provide continuous hemostatic protection.

2. The hemostatic agent formulation prepared by the method of claim 1, comprising: a) Sodium Polyacrylamide (1) in the range of 5-80 %W / W; b) Propylene Glycol (3) in the range of 1-2 %W / W; c) Glycerine (4) in the range of 1-2 %W / W; d) Ethanol (2) in the range of 50-80 %W / W; e) Ethyl cellulose (7) in the range of 0.5-1.5 %W / W; f) Hydroxypropyl cellulose (5) in the range of 2-4 %W / W; g) Polyvinylpyrrolidone (6) in the range of 3-20 %W / W; h) Colloidal silicon dioxide (8) in the range of 0.5-2 %W / W; i) Talc (9) in the range of 1-2 %W / W; j) Magnesium Stearate (10) and Alum (11) in the range of 1-2 %W / W; and k) Vitamin K2 (12) at 0.0024 %W / W.

3. The hemostatic agent formulation comprising the hemostatic agent formulation of claim 2 and a LPG propellant in a 1:1 ratio, filled into compatible spray containers using a certified gas filling machine.

4. The hemostatic agent formulation as claimed in claim 1, wherein a method of integrating a hemostatic agent into fabric, comprising treating the fabric with the hemostatic agent formulation of claim 1 and 2 through controlled applicationmethods selected from spraying, dip coating, or weaving, wherein the treated fabric is tested for hemostatic efficacy, flexibility, and durability, and is integrated into armor design to provide continuous hemostatic protection.

5. The hemostatic agent formulation as claimed in claim 1 and claim 4, wherein Armor comprising the hemostatic agent formulation integrated into a fabric layer, wherein the fabric layer comprises a two-layer design with a first layer of cotton in direct contact with a wearer's body for absorbing sweat and providing comfort, and a second layer comprising a combination of synthetic material and the hemostatic agent, wherein the treated fabric covers potential wound areas and provides targeted hemostatic protection.

6. The hemostatic agent formulation as claimed in claim 1, wherein the novel hemostatic agent formulation comprises a unique two-layer design, with a first layer of cotton in direct contact with the body for absorbing sweat and providing comfort, and a second layer comprising a combination of synthetic material and a hemostatic powder composition with gaps filled with cotton, ensuring that sweat does not penetrate the synthetic layer and keeping the novel powder composition safe and dry.

7. The hemostatic agent formulation as claimed in claim 1, wherein the hemostatic agent is integrated into the fabric of armor, covering potential wound areas and providing targeted protection and comfort to the wearer.

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