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Formulation development and manufacturingGetting the very best clinical and commercial value from your product means making sure it’s manufactured in a viable, efficient way and its benefits are delivered quickly and effectively.

At Sharp, we’re here to help you overcome development challenges, keep costs down and accelerate your time to market. We’ll work with you to develop a reliable formulation that gives optimal clinical outcomes and can be easily reproduced on a large scale, with excellent stability.

Our experienced team of formulation scientists works with state-of-the-art equipment and laboratory facilities, creating innovative formulations that work incredibly effectively with your active pharmaceutical ingredient (API).

Formulation development and manufacturingPre-formulation services:

  • Chemical compatibility and reactivity to packaging substrates.
  • Physical properties and product characterisation.
  • Accelerated degradation.
  • (API)-excipient interaction studies.
  • pKa determination.
  • Hygroscopicity studies.
  • Photostability of API.
  • Prototype evaluations.
  • Reverse engineering.

Formulation development services:

  • Phase I-IV formulation development and reformulations.
  • Determining blending times for tableting, encapsulation and analysis of characteristics (blending time, bulk density, content uniformity and flow characteristics).
  • Over-encapsulation and comparator product blinding.
  • Developing matching placebo products and comparator supplies.
  • Developing ethical, over-the-counter products, including tablets (immediate and controlled release), powders, liquids, suspensions, emulsions, creams, ointments and lotions.
  • Developing line extensions in the above dosage forms.

Technical services:

  • Troubleshooting commercial products.
  • Formulation optimisation and evaluation of new raw materials in existing products.
  • Technical transfer of products from R&D to production facilities.
  • Process optimisation and scale-up and assessment of current products.
  • Modernising existing manufacturing and clinical supplies processes.

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