Chemistry Tests, Liquid Capsules, Sterile Products for Clinical Trials

Aesica

Aesica was established in 2006 and is based in Nottingham, England and has GMP facilities for all dosage forms including, oral, topical, inhalation and sterile products. We also manufacture GMP spray dried materials.

Our business is to take your API and create the products that you will use in clinical studies. We provide the full integrated package of formulation, GMP manufacture, analytical method development and stability testing. We provide these services across the world to customers in USA, EU, Japan, Korea and Australia.more

Extended Release Oral Dosage Forms

Our objective at Aesica is to develop formulations to deliver the right amount of active compound to the right absorption site at the appropriate rate. We offer development support for everything from extended release oral dosage forms to instant release tablets and injectable products. Many compounds require moderation of their release over time. At Aesica we can provide this through several technologies including matrix tablets using a combination of cellulose derivates, coatings (of tablets or capsules), and bead technology (coating either a placebo bead, or a formulated bead). All products can be made in compliance with GMP for use in clinical trials. The entire development project is backed up by our in-house analytical chemistry and stability testing groups.

Analytical Chemistry Tests

Aesica provides the analytical chemistry support for all dosage forms. We can perform a range of analytical chemistry tests to ensure products meet all applicable standards and requirements. This data provides the backbone for all pharmaceutical development projects allowing decisions to be made regarding choice of ingredients, method of manufacture and shelf life determinations.

Aesica Analytical Chemistry offers expertise in HPLC, FT-IR, Dissolution, UV, Elisa, and a range of physical tests including laser particle size. R5 offers the complete range of ICH storage conditions. These services can be provided on a stand-alone basis for e.g. testing products being imported from outside the EU.

Spray Drying Pharmaceuticals

Spray drying of APIs can be used as a means of creating amorphous mixtures that are readily soluble. This offers the opportunity to overcome the poor solubility of many new compounds. Aesica can develop amorphous formulations for pharmaceutical spray dying, and manufacture in compliance with GMP.

The output powder can also be formulated into a suitable dosage form ready for human administration. The entire development project is backed up by our in-house analytical chemistry and stability testing groups.

Liquid Fill Capsules

Hard shell liquid fill capsules can be used to deliver liquid formulations. Aesica offers the opportunity to use this technology to handle highly potent compounds in a dust free (and safer) environment. Compounds that are particularly sensitive to moisture or air may also benefit from this formation approach. The shell is filled with either a warm mixture (that sets on cooling), or an oily liquid suspension or solution. All products can be made in compliance with GMP for use in clinical trials. The entire development project is backed up by our in-house analytical chemistry and stability testing groups.

Sterile Products for Clinical Trials

R5 is one of the few pharmaceutical development companies that offers aseptic, terminally sterilized, or lyophilized product development and GMP manufacture from a single site. The Clean Room Facility (CRF) is designed around a very large Grade A area (with background B). This approach avoids the risk of denaturing biotech compounds that can occur when using gassed isolators. We offer a reliable source of sterile products for clinical trials. Projects at R5 are backed up by both microbiological and analytical chemistry laboratories. Products are provide in infusion bags or vials and include solutions and suspensions.less

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Experts

  • Paul Titley

    Managing Director Contact Expert

    After a career in pharmaceutical development Paul has been advising pharma and biotech companies how to approach the development and manufacture of products for clinical trials for more than 14 years, and in that time has met with hundreds of companies.

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Aesica
Suite D, Breakspear Park, Breakspear Way
HP2 4TZ, Hemel Hempstead
United Kingdom

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