Solid state forms

This invention develops novel solid-state pharmaceutical forms with improved properties for pharmaceutical development and commercial application.

The Problem

Pharmaceutical development requires identifying optimal solid-state forms of active compounds to achieve desired properties including stability, bioavailability, dissolution rate, and manufacturability. Different crystal forms (polymorphs) of the same compound can exhibit dramatically different pharmaceutical properties, potentially impacting efficacy and safety. Discovering and characterizing solid-state forms is a critical but complex aspect of drug development that requires sophisticated analytical and experimental approaches. Controlling solid-state form during manufacturing is essential for consistency and regulatory compliance, but remains challenging in many cases.

What This Invention Does

This patent discloses novel solid-state forms of a pharmaceutical compound with superior properties compared to previously known forms. The invention includes methods for preparing these forms, characterizing their properties, and utilizing them in pharmaceutical compositions. By identifying and developing optimized solid-state forms, the invention improves the pharmaceutical performance and manufacturing characteristics of important therapeutic compounds.

Key Features

Optimized Stability. The novel forms demonstrate improved chemical and physical stability, extending shelf life and product viability.

Enhanced Bioavailability. The forms provide improved pharmaceutical properties, potentially requiring lower doses and improving therapeutic outcomes.

Improved Manufacturability. The forms can be manufactured using scalable processes, supporting commercial production at volume.

Regulatory Advantages. The characterized forms support regulatory filings and provide intellectual property protection for the pharmaceutical development.

Versatile Applications. The forms enable formulation into multiple pharmaceutical dosage forms including tablets, capsules, and injectable preparations.

Who Is Behind It?

Amgen Inc., one of the world’s largest biotechnology companies, developed this invention with eight scientists and researchers including Stephanie Azali, Darren Leonard Reid, and Ron C. Kelly. Amgen‘s world-leading expertise in recombinant therapeutics and pharmaceutical development indicates this represents an important compound in the company’s development pipeline.

Why It Matters

Solid-state chemistry and polymorph engineering remain critical capabilities in pharmaceutical development. The classification under A61P 35/00 (antineoplastic agents) indicates this invention relates to cancer therapeutics, a major focus of pharmaceutical research and development. As the pharmaceutical industry develops increasingly complex therapeutics, mastering solid-state properties becomes a key differentiator between successful and unsuccessful development programs. The intellectual property protection and regulatory advantages of optimized solid-state forms make this type of innovation particularly valuable in the highly competitive pharmaceutical industry.

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AU 2026201484 was published in the Australian Official Journal of Patents on 19 March 2026 and is open for public inspection. Patent applications represent inventions that are sought to be protected and do not necessarily reflect commercially available products.

Related Concepts

Crystal polymorphism is a critical consideration in drug development, as different solid-state forms of the same molecule can differ significantly in solubility, stability, and manufacturability. The bioavailability of a drug is directly influenced by its solid-state form, making polymorph selection a high-stakes decision. Antineoplastic agents – drugs used to treat cancer – are a particularly active area of pharmaceutical solid-state research given their therapeutic significance and commercial value.