The Technology behind AdaptiM3D
Pharmaceutical oral solid dose forms are the most significant drug delivery platform (80% of all medicines) with many thousands of products, addressing an array of disease areas, sold worldwide.
In product development, dose changes during clinical trials are commonplace. These changes are time consuming and costly; direct costs are < £1 M, but the lost patent life costs up to tens of millions of dollars in lost sales per dose change. The AdaptiMed technology allows a greatly increased range of actives to be used in 3D printing approaches, enabling rapid reformulation when a dose change is required: this saves time on the critical path to product launch and extends the period of sales that is covered by patent coverage.
The AdaptiM3D approach radically expands the range of active compounds that can be processed using extrusion-based 3D printing.
Novel technologies such as fused filament 3D printing of oral solid dose forms are recognised for their potential to produce highly functional tablets (with better control over microstructure and release characteristics), and can be developed using digital design approaches, which could overcome reformulation challenges as well as address clinical-manufacturing issues.
To date, the use of 3DP technology has been limited by the need to ensure both suitable rheological properties (to allow for extrusion) and mechanical properties (to enable filmament formation). Very few compounds can be formulated for use in this technology, due to these constraints.
AdaptiM3D approach removes the requirement to produce an extrudate with suitable mechanical properties for filament formation; as only rheological properties (to allow for extrusion) need to be considered, the formulation “space” is greatly expanded and this approach can be used with a wide variety of active compounds.
Facilities
AdaptiMed can provide access to a fully-licensed GMP manufacturing facility, with skilled and experienced staff available to support production and testing.
The firm will have access to fully-licensed facilities
Licensed GMP manufacturing facility
Skilled and experienced staff
Access agreed on a contract basis
Minimal expenditure enables “bootstrapping”
Minimal start-up costs and early profitability
Regulatory risks of the process are minimal
Standard materials in a novel process
Expert consultancy advice obtained
The current 3DP process
Extrusion and filament formation, followed by size reduction and tabletting
AdaptiM3D’s USP is that it provides a unique approach to development and manufacture of oral solid dose forms by providing ability to rapidly modify dose weight, dose size and dose performance in single step process using digital design and to quickly address requirement changes in clinical manufacture.
“Extrusion and direct deposition in a single mprocess
The current process stream for 3DP tablets is shown here. The highlighted component (the printer head) is the limiting factor, as it relies on a filament of very specific properties to be produced from upstream extrusion.
This is very difficult to achieve for a broad spectrum of pharmaceutical formulations. The AdaptiM3D technology is an enabler which eliminates and overcomes this barrier allowing 3DP to be exploited to address clinical-manufacturing and reformulation issues. This is achieved via our patented technology which directly integrates the printing process with the extrusion step. This also is much simpler than the traditional multi-process-step approach, and allows simpler reformulation and process development.
The AdaptiM3D technology can provide a highly-controlled range of release profiles:
Technology Capability
AdaptiM3D technology reduces timeline, footprint and cost while enabling advanced dose forms.
AdaptiM3D offers a comprehensive range of adaptive products designed to enhance mobility and independence for individuals with varying needs. Our innovative solutions cater to the specific requirements of each user, ensuring comfort and functionality. With a commitment to quality and accessibility, AdaptiM3D empowers individuals to lead more active and fulfilling lives. Discover how our products can make a difference today.
The AdaptiM3D approach enables the use of 3DP technology with a wide variety of active compounds, by obviating the need for filament formation. The use of a sophisticated and exceptionally well-controlled x-y-z platform facilitates the production of a range of dose form shapes sizes and geometries. Combined the team’s deep understanding of pharmaceutics and pharmaceutical production engineering, this capability enables a wide range of release profiles (from immediate to controlled release) to be developed readily. The intensified one-step nature of the process allows for rapid formulation and production of clinical materials.
This technology can be applied to a wide variety of compounds, across different therapeutic areas. The ability to respond very rapidly to the need to change the dose of a formulation – on the critical path, during a clinical trial – will be of use in many oncology product development situations. In addition, the flexibility of the approach and the rapidity of manufacturing may be of use in rare disease product development. The substantially lower costs of the AdaptiM3D approach, compared to conventional clinical supply manufacturing, will enable many more trials to proceed than might otherwise have been the case, enhancing provision for patients in this field.