Company: MDCXW
Filing Date: 2025-05-27
Form Type: S-1
Source: 0001062993-25-010394
Chunk: 101

Company: Medicus Pharma Ltd.
Filing Date: 2025-05-27
Form: S-1
Chunk 101
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L of doxorubicin gel of the following composition. The doses in the headline refer to the base of doxorubicin. The current formulation contains an overage of 5% of drug substance.

Controls of Critical Steps and Intermediates

The following are fundamental to the production of arrays according to GFE Protocol P171016-1-R3.

•Preparation:Assembly and gel formulation.

•Deposition 1 (Tip Loading):Deposition of the formulation containing active doxorubicin and excipients.

•Deposition 2 (Backing Plate):Deposition of formulation containing only excipients to create the backing plate to the needle structure.

•Drying:Centrifugation of the array under controlled temperature and humidity conditions until moisture is removed from the formulation.

•Demolding, Cutting, Desiccation, and Storage: Removal of the arrays from the molds, trimming, and storage in a desiccator box in a controlled refrigerated environment for 72-96 hours.

Critical to quality parameters 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

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| 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)               |     | Limit                                                                                                                                                                         |