System for the formulation and topical application of pitavastatin-loaded nanoemulgel for the treatment of diabetic wounds
The integrated system for formulating and applying pitavastatin-loaded nanoemulgel addresses the limitations of conventional treatments by ensuring uniform nanodroplet formation and stability, enhancing drug penetration and bioavailability for effective diabetic wound healing.
Patent Information
- Application Number
- DE202025107020
- Authority / Receiving Office
- DE · DE
- Patent Type
- Utility models
- Current Assignee / Owner
- Filing Date
- 2025-11-15
- Publication Date
- 2026-01-08
- Estimated Expiration
- 2035-11-30
AI Technical Summary
Conventional treatments for diabetic wounds using topical antibiotics and dressings are inadequate due to impaired vascularization, insufficient cell regeneration, and oxidative stress, while statins like pitavastatin face challenges with low solubility and limited skin permeability, necessitating a specialized delivery system for sustained release and stability.
An integrated system and device for formulating and applying pitavastatin-loaded nanoemulgel using high-performance homogenizers, ultrasonic dispersion, and a temperature-controlled mixing chamber to ensure uniform nanodroplets and stability, with a gel matrix for enhanced drug encapsulation and application.
The system achieves improved drug penetration, retention, and bioavailability, ensuring reproducible and scalable production of nanoemulgel for effective wound healing in diabetic patients.
Abstract
Description
Field of invention:
[0001] The invention relates to the field of pharmaceutical and biomedical engineering, in particular a system and a device for the production, stabilization and application of pitavastatin-loaded nanoemulgel formulations for the effective treatment of diabetic wounds. Background of the invention:
[0002] Diabetic wounds are among the most serious complications of diabetes mellitus, often leading to delayed healing, chronic ulceration, and, in extreme cases, amputation. Conventional treatments with topical antibiotics and dressings are often inadequate due to impaired vascularization, insufficient cell regeneration, and oxidative stress in diabetic tissue. Statins, primarily known for their lipid-lowering effects, exhibit significant pleiotropic properties, including angiogenic, anti-inflammatory, and antioxidant effects that support wound healing. However, their low solubility and limited skin permeability restrict their topical therapeutic use. Pitavastatin, a potent statin, offers remarkable wound-healing potential but requires an advanced delivery system to ensure sustained release, stability, and targeted action.Conventional formulations do not achieve sufficient drug penetration and retention in the wound area. Therefore, there is a need for a specialized system or device for the formulation, homogenization, and application of a pitavastatin-loaded nanoemulgel with controlled particle size, stability, and bioavailability for efficient wound healing in diabetic patients. Summary of the invention:
[0003] The present invention provides an integrated system and device for the formulation and application of a pitavastatin-loaded nanoemulgel for the treatment of diabetic wounds. The system comprises a nanoemulsion manufacturing unit with high-performance homogenizers and ultrasonic dispersion components for generating uniform nanodroplets, thereby ensuring efficient drug encapsulation and stability. The device further includes a temperature-controlled mixing chamber and a gel matrix incorporation unit for mixing the nanoemulsion into a topical gel base. This results in a homogeneous, thermodynamically stable nanoemulgel formulation.
[0004] The present invention relates to an integrated system and device for the production and application of a pitavastatin-loaded nanoemulgel for wound healing in diabetic patients. The system comprises a nanoemulsion production unit with high-performance homogenizers and ultrasonic dispersion components for generating uniform nanodroplets, ensuring efficient drug encapsulation and stability. The invention also includes an application system for the uniform distribution of the nanoemulgel onto diabetic wounds, thereby improving local absorption, moisture retention, and delayed drug release. The system ensures reproducibility, high formulation stability, and superior therapeutic efficacy. The integrated device offers a cost-effective and scalable solution for the production of nanoemulgel-based drug delivery systems for the treatment of diabetic wounds. Detailed description:
[0005] The system comprises a sophisticated nanoformulation apparatus for the production and application of pitavastatin-loaded nanoemulgel. The apparatus includes a stainless steel mixing chamber connected to a high-performance homogenizer that can be operated at variable speeds between 5,000 and 25,000 rpm. This component enables the formation of a fine nanoemulsion of oil, surfactant, co-surfactant, and an aqueous phase containing 2.5 wt% pitavastatin.
[0006] The nanoemulsion manufacturing unit integrates an ultrasonic probe system with a frequency of 20 kHz to ensure the uniformity of the nanodroplets and prevent phase separation. The temperature in the mixing chamber is maintained between 25 °C and 35 °C by a thermostat system to prevent drug degradation and maintain emulsion stability.
[0007] A second module is used for the nanoemulgel formulation. The prepared nanoemulsion is transferred to a gel incorporation unit. This unit contains a planetary stirrer and a pH controller to ensure optimal gel consistency and biocompatibility. The gelling agent, for example Carbopol 940, is uniformly dispersed, resulting in a smooth, viscous nanoemulgel with optimal spreading and adhesive properties for topical application.
[0008] The system also includes a cleaning and degassing chamber that removes air bubbles and volatile residues from the final product, ensuring a uniform texture and stability. A filtration unit equipped with sterile membrane filters maintains aseptic conditions throughout the entire process.
[0009] The nanoemulgel storage and dispensing module is designed as a temperature-controlled container connected to a precision applicator nozzle or syringe dispenser, enabling hygienic and controlled application to diabetic wounds. The dispenser can be equipped with adjustable pressure and flow regulators for uniform coverage.
[0010] In another embodiment, the device can integrate sensors to monitor viscosity, droplet size, and zeta potential during the formulation process to ensure consistency and compliance with pharmaceutical standards. The system components are made of non-reactive, corrosion-resistant materials suitable for pharmaceutical-grade manufacturing.
[0011] The integrated design allows for scalability for both laboratory and industrial production. The modular design of the device facilitates easy cleaning, sterilization, and maintenance. The device offers a sustainable, automated, and reproducible method for the production of high-quality pitavastatin nanoemulgels suitable for clinical and commercial applications.
Claims
[1] A system comprising a nanoemulsion manufacturing unit with high shear homogenization and ultrasonic dispersion capability for the production of a pitavastatin-loaded nanoemulsion with controlled nanodroplet size. [2] System according to claim 1, comprising a device with a gel embedding chamber with temperature and pH control for uniform mixing of the pitavastatin nanoemulsion into a polymer-based gel matrix to form a stable nanoemulgel. [3] System according to claim 1 or 2, comprising a storage and dosing device with a temperature-controlled reservoir and a precision applicator for hygienic and controlled topical application of pitavastatin-loaded nanoemulgel to diabetic wounds. [4] System according to claims 1 to 3, which combines nanoemulsion formation, gelation, purification and controlled drug release and is configured to ensure the stability, uniformity and bioavailability of the active ingredient in the treatment of diabetic wounds.