ADD Technologies - Drug Development Services and Drug Delivery Platforms

ADD Technologies is an independent pharmaceutical company based close to Basle, Switzerland. ADD is experienced in the development of solid oral-dosage forms with a focus on modified release products and fast-dissolving tablets with taste masking, both based on multiple unit formulation concepts.

ADD offers services for formulation development, as well as process development for modified release drug-delivery systems for oral administration (for NCEs, generics and line extensions) ranging from development and clinical supplies manufacturing, to full-scale GMP production of intermediate (e.g. pellets) and finished solid dosage form products.

ADD's capabilities include:

• Pelletisation, drug layering and coating
• Granulation
• Tablet compression
• Tablet coating
• Capsule filling
• Organic solvent processing

All these technologies are supported by a very experienced project management and are in line with the current industry standards.

With our closely related manufacturing facilities in Germany and the United States we focus on dosage form design using both contemporary and proprietary technologies. Examples of our proprietary drug delivery systems include:

• CPS™ pelletisation technology
• MicroPx™ technology – micro pellet delivery system
• ProCell™ technology
• Fast dispersible tablets together with taste masking
• Timed release pellets
• Targeted delayed release

From the initial concept in product and formulation development, to feasibility studies evolving to process scale up, submission batch manufacture, clinical / bio-batch samples, technology transfer and production, we can offer either individual service modules or complete packages. Our teams have a long track record in developing products from a broad list of categories including NCE, line extensions, generic drugs and over-the-counter products.

CPS PELLETISATION TECHNOLOGY

The innovative CPS; pelletisation technology is a direct fluid-bed pelletization technology covered by patents.

Its special features are generated by a modified fluid-bed rotor system with a conical-shaped rotating disc plus additional devices for directed movement of coated particles. To start processing, no inert starting beads are required. Spraying of various liquids (organic and inorganic) as well as dry powder is also possible. By means of rolling particles' movement, CPS pelletisation technology clearly defines the densification of particles.

The product characteristics are reflected in spherical and smooth pellet surfaces, high density and loading of drug substance, low porosity of pellets, low attrition and friability, and dust-free surfaces..

MICROPX TECHNOLOGY – MICRO PELLET DELIVERY SYSTEM

The Micro Px technology consists of a continuous fluid-bed process. After liquid spraying and coating of APIs, generated micropellets are classified by applying a vertical online air sifting system. The entire process constitutes of a well-balanced system of spray drying and consecutive drug layering. The Micro Px technology process results in manufacturing of high drug loaded matrix-type micropellets. Drug loadings of produced pellets can be up to 95%.

Our Micro Px technology process can be also applied for taste masking, which usually has an ideal particle size distribution between 200µm to 400µm. Any functional excipient can be integrated into the coated micropellet matrix.

The product characteristics are reflected in high drug loading (<95% feasible), small pellets size (50µm up to 500µm) and narrow size distribution, spherical and smooth surfaces. The pellets are ideal for additional functional coating steps, e.g. to obtain taste masked products (macrolide antibiotics, etc.).

PROCELL TECHNOLOGY

ADD offers innovative technologies for the development and production of solid dosage forms. We have process technology for the manufacture of very highly concentrated spherical particles:

• Modified fluid-bed granulation process, in particular performed as melt granulation, with no inert starting beads required and controlled particle movement
• Controlled material circulation through special air flow design

Product characteristics:

• Very high material concentration (up to 100%)
• Particle size range from 50µm to 1,500µm
• High density and low porosity
• Particularly suitable for processing of products with inherent stickiness
• Processing of excipients and drug substances

TARGETED DELAYED RELEASE

ADD has established a platform technology, which is suited to control the onset of drug release and release rate of oral delivery devices with superior reproducibility and low system variability. Multiple pulse systems can also be realised with this technology. Drug release is pH-independent, and the final dosage form is presented as a hard-gelatine capsule, tablet or sachet.