Company: MDCXW
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001062993-25-006485
Chunk: 16

Company: Medicus Pharma Ltd.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1
Chunk 16
---
 include:

• Dissolution and homogeneity of all materials during mixing.

• Centrifuge rpm and quality/degree of tip loading.

• Dilution and viscosity of gels relating to accurate, consistent deposition.

• Duration and speed of drying steps affecting water content and flatness of arrays.

• Temperature maintained (2-8 C) within centrifuge with impact on drying time and on doxorubicin stability.

• Refrigeration of arrays once fabricated.

• Post-fabrication, moisture content of arrays reduced to 5%, as measured by loss on drying.

In-Process Controls: D-MNA; P-MNA

                14

                    In-Process Controls (Engineering)
                     
                    Limit

                    Master mold fabrication via milling process
                     
                    CAD/CAM of all suitable material rendering required geometry for microneedles

                    Production molds fabricated from polydimethyl siloxane
                     
                    Spun in the same centrifuge to fabricate the arrays such that forces and angles used to make production mold mirror those used to fabricate the arrays. Production molds inspected after every production cycle to ensure integrity of the needle forms-Protocol P171016-1 R3 governs this process.

                    Fabrication of each fixture necessary for array production
                     
                    Protocol P171016-1 R3 provides these parameters

                    In-Process Controls (Formulation)Dissolution of all materials in gelformulation
                     
                    LimitVisual inspection

                    Viscosity of the gel
                     
                    Verified by cone plate viscometer torque reading; Brookefield Viscometer DVII+ calibrated at every run

                    pH of the gel
                     
                    A pH of between 4.5 and 5.1 is sufficiently acidic. Follow procedure for dilution of gel, use of pH probe, and calculation (Determination of the pH of SkinJect Formulations)

                    In-Process Controls (Array Fabrication)
                     
                    Limit

                    Deposition and centrifugation.
                     
                    Deposit approximately 0.5 ml per 2 x 5 production mold. The centrifuge is run for 30 minutes at 5,500 rpm at 15C.

                    Doxorubicin stability
                     
                    Temperature maintained within centrifuge at 15C that impacts drying.Refrigeration of arrays once fabricated at 2-8°C

The flow chart, below, describes in more detail the critical steps and manufacturing parameters