Pharmaceutical Development - Early Phase

Source: Almac Group
Pharmaceutical Development - Early Phase

Almac’s experienced formulation scientists can develop a range of oral dose formulations for early stage clinical trials.

With both non-GMP and GMP facilities, flexible and efficient solutions are provided to develop a fit-for-purpose formulation for your early phase clinical trial.

Drug in Bottle / Liquid in Bottle

“Drug in Bottle” or “Liquid in Bottle” offers a flexible solution for your early stage clinical studies. Taking your anticipated dose range into account, we will complete solubility screening experiments with various co-solvents. We will then assess solution stability to ensure there is sufficient shelf life to cover the intended period of time.

If the clinical supplies are being provided in a “Drug in Bottle” format, we will prepare a pharmacy manual to accompany the GMP drug product. This ensures that critical information about reconstitution and solution stability is transferred to the pharmacist at the clinic.

Drug in Capsule

Filing drug or active pharmaceutical ingredient (API) directly into capsules is one of the quickest ways for you to enter Phase I clinical trials whilst requiring a minimum quantity of API. This approach can reduce time and financial investment at an early stage in the development process, by minimising the API required and reducing the scope of analytical work required to support your clinical trial application.

Manual / Semi-Automated Filling

For low volume capsule supply we can provide manual API filling of capsules. We can also use capsule boards which are engineered to suit the characteristics of your particular API and the doses required.

Automated Processing

Using the Xcelodose® system, we have the ability to fill formulations or API directly into capsules with a high level of accuracy. This system can dispense amounts from 100 micrograms up to 100 milligrams and beyond, into capsules from size 00 to 4. Dosing directly into capsules can reduce the amount of API required.

Conventional Capsule / Tablet Formulations

Developing an initial solid oral dose formulation is still the preferred choice for many of our clients. Our highly skilled team has significant expertise in developing initial prototype formulations and identifying a number of potential formulations. Their dedicated work can provide you with the optimum formulation and process to bring forward to GMP manufacture.

We have the technology available to work with APIs with varying properties:

  • Dry powder blending
  • Roller compaction
  • Granulations (aqueous and solvent capabilities)
  • Vacuum drying, tray drying and fluid bed drying
  • Spray drying (aqueous and solvent capabilities)
  • Automated capsule machines
  • Instrumented tablet presses
  • Coating (aqueous and solvent capabilities)
  • Sacheting capability
  • Bottling and blistering for stability assessment

We believe in quality-by-design. That’s why, when we develop blending, roller compaction or granulation processes, we look to the future to ensure your formulation can be scaled up for later stage clinical supply.