Artificial Intelligence-Assisted Quality by Design Development and Optimization of Baicalein-Loaded Nanostructured Lipid Carriers (NLCs) for Targeted Topical Therapy of Psoriasis

Artificial Intelligence-Assisted Quality by Design Development and Optimization of Baicalein-Loaded Nanostructured Lipid Carriers (NLCs) for Targeted Topical Therapy of Psoriasis.

Introduction.

Psoriasis: A Chronic Immune-Mediated Skin Disorder.

Proposed Innovative Solution AI-Guided Baicalein-Loaded Nanostructured Lipid Carriers (NLCs) Platform.

[image] PROPOSED INNOVATIVE SOLUTION A1-GUIDED BAICALEIN-LOADED NANOSTRUCTURED LIPID CARRIERS (NLCs) PLATFORM From Smart Design to Targeted Psoriasis Therapy ACTIVE MOLECULE Baicalein Natural flavonoid y—ties KEY BENEFITS OF THE PROPOSED PLATFORM A1 ANN-BASED FORMULATION PREDICTION Layer A1 & ANN and q. POI Drug Relog ANN QbD INTEGRATED WITH DoE FOR OPTIMIZATION CMA OPTIMIZED BAICALEIN- LOADED NLCs CPP CQA Identification of CMAs & CPPs Establishment of Design Space Robust, Reproduc & Formu Development INCORPORATION INIO glOADHESlVE NLCS in hyåogel . Rudy THE JOURNEY: FROM A1 TO TARGETED THERAPY t DoE DoE fM repoduci& ENH%ED STABILITY and Incorporated DEEP SKIN PENETRATION lay*' APPLICATION & THERAPEUTIC OUTCOMES Appkün Topica I Application with Enhanced penetration & IMPROVED SAFETY thera*u6C with miünal Side eHetS TARGETED PSORIASIS THERAPY Targeted Psoriasis Therapy BETTER ourcoug me*ment q• life.

Why Artificial Intelligence in Formulation Development ?.

Artificial Neural Network (ANN)-Driven Formulation Development.

[image] HOW A1 WORKS IN FORMULATION DEVELOPMENT A1 leverages data, machine learning algorithms and predictive modeling to design, optimize and accelerate formulation development with higher success rate and lower cost. O O o D O DE 1. Literature Search (Google Scholar, PubMed, ScienceDirect) Collect research articles related to NLC formulations and experimental responses Use dataset from URL 2. Dataset Collection (Composition Of N LC formulations + Experimental respon ses) 3. Data Pre-processing • Remove duplicates • Standardize units 4. A1 Model Developnment (Using A1/ML Tools) 5. A1 Prediction Predict particle size • Predict PDI Predict entrapment efficiency 7. 8. 9. https://.... . (your dataset URL) • Extract data containing formulation variables (Input) and experimental responses (Output) Scholar ScienceDirect A1/ML Tools • Handle missing values Normalize data Develop and train A1 model Validate model performance • Select best performing model • Predict ze ta potential Predict drug release (optional) • Identify influential variables Desi gner IBMspss MODELER OJ—J Rapid i etc. Of O • Select the best predicted for optimization Design-Expert@ Enter selected factor ranges Perform CCD/BBD optirnization Laboratory Preparation Experimental Validation Generate optimum formulation Prepare optimized NLC formulation in laboratory • Evaluate and validate the optimized formulation experimentally BENEFITS OF A1 IN FORMULATION DEVELOPMENT Reduces trial and ermr Improves Saves time prediction accuracy and cost Identifies critical formulation factors Enhances success rate and quality.

Research Methodology.

[image] WORKFLOW OF THE PROPOSED RESEARCH A1-Driven Innovation for Optimized Baicalein-Loaded NLCs for Targeted Topical Therapy of Psoriasis 01 LITERATURE DATASET DEVELOPMENT • curate published Baicalein. loaded and NLC formulations. • formulation and critical quality (CQAS), • perform normalization and feature selection A1-BASED ANN MODEL DEVELOPMENT • Train. an d test tho ANN using the curated dataset _ • Dove lop p to estimate C QAs_ 02 06 ANTI-PSORIATIC EVALUATION • eX vivo Skin pe and skin retention. • Eva I uate in vivo a n t i -psoriatic efficacy. Optimized Baicalein -Loaded NLCs for Targeted Topical Therapy Of Posriasis stability and • Identify the optimal Be -loaded NLC AL A1-ASSISTED QbD OPTIMIZATION 03 • Apply Design of Experiments (DOE) to CMAs and CPPs. • Esta the n Space and validato tho A1-prodictod • Select a and reproducible optimized for Tw lotion. PREPARATION OF OPTIMIZED 05 CHARACTERIZATION OF OPTIMIZED FORMULATION • Dotormino particle Size. Zeta Potential. Entrapment Efficiency and Drug Loading. • Perform FTIR. OSC XRD analysis. • Evalua to in vitro drug ond Stability. BAICALEIN-LOADED NLCs • Prepare optimized Baicaleirrlooded NLCS using lipid and SMIOctant terns • Incorporato tho optimized NLCs a topical hydrogel for pscmasis 04 Bottor patient Improved skin pen etrati on and roto ntion an ti- psoriatic KEY OUTCOMES & IMPACT.

Expected Product Profile.

[image] TARGET CHARACTERISTICS OF THE OPTIMIZED BAICALEIN NLC GEL DESIGNED FOR DEEP PENETRATION, SUSTAINED DELIVERY & ENHANCED ANTI-PSORIATIC EFFICACY 01 02 03 04 05 06 PARTICLE SIZE: < 200 nm Ultra-fine particles ensure deeper skin penetration, uniform distribution and optimal interaction with bacterial biofilms. POLYDISPERSITY INDEX (PDI): < 0.30 Narrow Size distribution indicates a homogeneous nanoparticle population, ensuring excellent formulation Stability. ENTRAPMENT EFFICIENCY (EE): > 85% High encapsulation of bioactive compounds (baicalein, curcumin, berberine) for maximized therapeutic potential. SUSTAINED DRUG RELEASE: up TO 24 HOURS Controlled and prolonged release maintains drug levels at the target site, minimizing dosing frequency. IMPROVED SKIN RETENTION & BIOFILM PENETRATION Enhances localized drug concentration. biofilms and sustains drug at the Site for effective antimicrobial action. ENHANCED ANTI-PSORIATIC EFFICACY Reduces inflammation, scaling and erythema while promoting skin healing and restoring DEEPER PENETRATION PROLONGED TARGETED & EFFICIENT THERAPY healthy Skin barrier. REDUCED SIDE EFFECTS & IRRITATION BETTER PATIENT COMPLIANCE.

Innovation & Uniqueness.

[image] A1-ASSISTED QbD PLATFORM Integrates Artificial Neural Networks (ANN) with Quality by Design (QbD) to enable predictive formulation development, minimizing conventional trial-and-error experimentation. PRECISION ANTI- PSORIATIC THERAPY A1-assisted optimization enables reproducible formulations With enhanced anti-inflammatory, antioxidant and anti-psoriatic therapeutic INNOVATIVE QbD-Al NANOMEDICINE 02 BAICALEIN-BASED NANOMEDICINE Develops Baicalein-loaded Nanostructured Lipid Carriers (NLCs) to enhance drug solubility, skin penetration and therapeutic efficacy for psoriasis management. TARGETED TOPICAL DRUG DELIVERY Optimized NLCs improve skin retention, controlled drug release and localized delivery to psoriatic lesions while reducing systemic exposure. performance. Anti- Inflammatory SCALABLE & INDUSTRY-READY TECHNOLOGY Designed using QbD principles to ensure formulation robustness, regulatory compliance, scalability and commercialization potential. Antioxidant Activity Anti-psoriatic Effect Formulations principles for Robust Formulation Compliance Scalability & Reproducibility.

Intellectual Property Strategy.

[image] PATENT ROADMAP —• FROM INNOVATION TO INTELLECTUAL PROPERTY & COMMERCIALIZATION A1-Assisted QbD Formulation Optimization Protect ANN -assisted Q bD platform Predictive development of Baica N LCS A1-driven workflow for prediction & design space A1/ANN-based Predictive Optimization Methodology 02 Optimized Baicalein-Loaded NLC Formulation & Process Novel Baicalein NLC formulation Optimized lipid-surfactant corn on hydrogel for psoriasis therapy Baica lein- loaded NLC Composition 03 Ytvi Trademark Registration unique brand name & Market recognition & branding protection Commercial identity for NLC hydrogel 04 Technology Transfer & Licensing Transfer & to pharma/biotech/d erma Scale-up manufacturing & commercia I i zation e University-industry 05 PATENT Examination & prosecution to examination Refine claims & address Patent granted & protection 06 Commercialization & Market Impact Market reach & Better patient outcomes (From Lab to Life) KEY PATENTABLE ELEMENTS Manufacturing Topical Hydrogel Formulation QbD Design Space & DoE Strategy Enhanced Skin Retention & Controlled Drug Release . Innovating Today • Protecting Tomorrow • Transforming Patient Care.

Business Model.

[image] COMMERCIALIZATION STRATEGY From Innovation to Impact: A Roadmap for Market Success TARGET CUSTOMERS • Pharmaceutical companies developing advanced dermatological and topical drug delivery products. • Hospitals and dermatology centers for clinical management Of psoriasis and Other chronic inflammatory skin disorders. • Specialized dermatology clinics providing advanced topical therapies for psoriasis treatment. • Healthcare distributors and for product commercialization and market distribution. REVENUE STREAMS Sales Of Baicalein-loaded NLC topical hydrogel for targeted psoriasis therapy. Technology licensing Of the A1-assisted ObD fortnulation platform and patented Baicalein-loaded NLC technology. • Intellectual property commercialization through patents and technology transfer agreernents. research A1—assisted services for pharmaceutical and biotechnology companies. GROWTH & FUNDING OPPORTUNITIES • Startup incubation university innovation and in Centres. • Government funding frOrn agencies such as BIRAC, ANRE DST. ICMR and MSME for technology and commercialiation. Industry partnerships for pilot-scale production. Clinical validation, and market launch. 03 MARKET SUCCESS WHO WE SERVE Sewing innovators, healthcare pmviders. specialists and distribution partners Who drive better Skin health solutions. HOW WE CREATE VALUE Delivering cutting-edge NLC-based therapy, proprietary technology. IP assets and expert formulation HOW WE GROW Building through incubation, strategic funding and Strong collaborations to scale innovation from lab to FINANCIAL SUSTAINABILITY Diverse revenue stream s growth and stability. FOCUS with adva topicd VALUE A1-driven FUTURE INNOVATIVE TECHNOLOGY A' QbD platfortY' for precision la tiOn. REGULATORY READINESS Compl a nce• focu sed fa Ste r approvals. ENABLERS FOR LONG-TERM SUCCESS STRATEGIC PARTNERSHIPS s with i and sta GLOBAL IMPACT I mprm"ng patient and quality Of life ti•uough.

Technology Readiness Roadmap.

[image] Roadmap from Research to Commercialization better formulations 02 03 04 EVIDENCE-BASED DEVELOPMENT Validated for safety and efficacy TRL 2—3: Technology Concept & A1 Model Development • Curate 150—300 literature-derived NLC formulations. • Develop and validate the Artificial Neural Network (ANN) predictive model. • Identify the optimal formulation using A1-assisted optimization. TRL 4: Laboratory Validation • Prepare the optimized Curcumin—Berberine co-loaded NLCs. • Incorporate NLCs into a bioadhesive topical gel. • Perform physicochemical characterization and validate A1 predictions. TRL 5—6: Preclinical Validation • Evaluate antibiofilm and antimicrobial efficacy against MDR pathogens. • Conduct ex vivo skin permeation and retention studies. Perform in vivo diabetic wound healing studies, safety assessment and histopathological evaluation. TRL 7—9: Clinical Translation & Commercialization • Scale-up manufacturing under Quality by Design (QbD) principles. • Complete regulatory documentation and clinical evaluation. • Secure intellectual property, establish industry partnerships and commercialize the product through technology transfer or startup incubation. TRANSLATION TO IMPACT Bridging research to real-world use IP & PARTNERSHIP FOCUSED 9 protect, collaborate and grow COMMERCIAL SUCCESS Delivering value to market.

Budget Plan.

Budget (₹ 75,000). Budget Head Amount (₹) Purpose Consumables 60,000 Lipids, surfactants, Baicalein, Carbopol, solvents, microbiological media, reagents, chemicals, disposable laboratory supplies Non-Consumables 10,000 Small laboratory equipment, glassware, micropipettes/accessories, reusable laboratory items Contingency 5,000 Unforeseen experimental expenses, minor repairs and miscellaneous laboratory requirements Total Budget 75,000 Project Cost.

Thank You Questions & Discussion.