Acino

Expertise in advanced and refined drug application systems is our core technological competency, both in development and manufacturing. As a partner of the research-driven pharmaceutical industry, Acino works on a comprehensive pipeline of products for oral administration. Our pharmaceutical experts are involved in drug development of new formulations of existing medicine already at early stages.

Our technology know-how encompasses:

• Oral modified release forms
• Oral dispersible forms

On July 25, 2016, Acino International AG and Acino Pharma AG (together “Acino”) signed an agreement to divest Acino’s transdermal patch and implant business to Luye Pharma Group Ltd. (“Luye”). The divestment includes Acino’s transdermal manufacturing operations, distribution, and R&D capabilities. Closing of this deal is expected before the end of 2016.

Acino will retain the marketing rights to certain transdermal patches in its strategic emerging markets.

Acino has vast experience in the development and manufacture of multiparticulate systems (for example using the active ingredients oxycodone and metoprolol) and supplies leading European generics companies with its innovative products.

The smallest functional unit of a multiparticulate system is typically a pellet. Pellets are small, free flowing, spherical particles which can be obtained through aggregation of fine powders or granulates of active ingredients and excipients using the appropriate technical equipment.

Coated pellets
Manufactured by coating a starter particle by means of suspension / solution layering in a fluidized bed.

Matrix pellets
Produced by extrusion / spheronization, direct pelleting or melt extrusion.

Pellets are commercially available in different dosage forms. They can be filled into capsules or sachets / stick packs. Alternatively, they can be combined with suitable excipients and pressed into tablets, so called Multiple Unit Particulate Systems (MUPS tablets). The drug release from this dosage form can be defined by the formulation of the tablet and the pellets.

Oral dispersibles are loaded with an active ingredient and are suitable for application to the oral cavity. The active ingredient can be either dissolved or suspended in the polymer matrix.

Our in-house technology focuses on rapidly dissolving tablets (ODTs), films (ODFs, thin polymer films) and pellets (in stick packs).

Oral dispersibles offer numerous advantages:

• They can be easily administered without liquids
• Ideal drug delivery form for active ingredients with a high first pass effect which may be bypassed with a possible buccal absorption
• Rapid onset of action thanks to a quick dissolution of the films
• Due to the adhesion on the oral mucosa, spitting out the films is not possible

These characteristics predestine ODFs for use in pediatric, geriatric and veterinary medicine.

Acino offers fully integrated services. Whether you opt for the entire service chain or have individual needs, we provide top-quality work, something every customer can rightfully expect from us.

The development of a suitable drug delivery system can offer added protection for your product portfolio, access to a broader labeling with additional indications, improved efficacy and safety of your product, and higher patient comfort and compliance.

Benefit from our broad technology expertise
Acino possesses a vast spectrum of technologies for the modified drug release ranging from instant drug release to release of the active ingredient over several months. Our experts master broad-based know-how in complex oral systems to develop the optimal drug delivery system for your product.

Everything from a single source, from us
We start with feasibility studies and take projects through to marketing approval and manufacture.

Let us develop your product for you
We developed the methodological approach into routine, however, every specific detail still requires both scientific and creative excellence. Exclusive and protected technologies help to reduce development times, costs and risks.

Quality wins, for contract services and own projects alike
Currently Acino works on numerous research and development projects, either as partner of locally or internationally acting pharmaceutical companies or on our own initiative to develop projects which will be available for licensing on a global basis.

With our proven expertise in formulating and manufacturing “difficult to make” products, we started a new era: proposing an unmatched range of tools for life cycle management (LCM) for your brand.

Four versatile technology platforms spanning from immediate release (IR) to release profiles over six months (CR, controlled release) are the starting point for your reformulation activities to come up with a new, innovative dosage form of your molecule.

In the oral category for decades the typical line-extension was a once-a-day form, thus improving patient compliance. Nowadays aspects such as designing pharmacokinetics (e.g. bioavailability enhancement) or slowing down the impact of loss of exclusivity (LoE) are triggering proactive reformulation concepts.

Your benefits:

• Patient-centric drug delivery creates competitive advantages
• Extra period of market exclusivity

Key points to consider:

• Start early
• Define a clear regulatory strategy
• Find a professional partner

Our drug regulatory experts have a broad-based knowledge of the regulatory requirements for the different products and indications and know the local regulatory requirements around the globe inside out.

From early development, we provide regulatory advice throughout the commercial life of a product. We support contract partners in the provision of regulatory relevant documentation, ensure regulatory compliance for all products on the market and provide regulatory intelligence services.

Our specific expertise includes:

• Design of regulatory strategies, starting from the inception of a new product idea
• Provision and assembly of complete registration dossiers for all development and marketed products
• Worldwide submission and registration

Pharmaceutical companies value Acino as a prime contract manufacturer of superior quality products. Acino covers the entire spectrum of services for business customers, from the strategic sourcing of active ingredients to the manufacture and packaging, in a highly competent and reliable fashion.

We offer:

• Contract manufacturing and packaging of solid oral dosage forms (Swissmedic / RHI, GCC, KFDA), transdermal therapeutic patches and biodegradable implants (EU GMP / Canada)
• Clinical trial medication

Our core competencies include:

• Innovative technologies, especially for pellet-coating
• Expertise in modified release formulations (targeted drug release profiles)
• Manufacturing with use of organic solvents (granulates, pellets, film coating) and their environmentally friendly recovery
• Expertise in the sourcing, manufacturing and handling of narcotic substances
• Galenical development and solving of formulation-related problems
• Process development and scale-up (full range from laboratory to production scale)
• Release and stability testing in own laboratories including analytical assessments for the clearance of pharmaceuticals / EU release