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.
For early phase First-in-Human (FIH) supplies, we offer a range of solutions:
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.
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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.
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.[/expand]
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.
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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.
A Streamlined Progression from Development to Clinic
Our non-GMP development services offer you greater flexibility and speed. With a state-of-the-art facility, we are able to focus on lab-scale experiments with batch sizes ranging from <1kg up to approximately 5kg scale for most technologies. With both our non-GMP and GMP facilities residing at the same site, we can provide a seamless transition between the development and GMP phases of projects in early stage development.
By deliberately ensuring good integration of all technologies in both the non-GMP and GMP facilities, we can conduct non-GMP work efficiently then transfer rapidly to GMP manufacturing. Essentially, our seamless process speeds up your overall project timeline to clinic and removes risks from your clinical manufacturing activities.
Improving the Bioavailability of your Compound
Many APIs have poor physicochemical properties that may struggle to get sufficient exposure when dosed to patients. We can develop a variety of formulations that potentially offer improvements in the bioavailability of your compound.
Through our advanced techniques, we can offer:
- Micronisation of API
- Spray dried amorphous material (aqueous & solvent capabilities)
- Solubilised / lipid-based systems
Never limiting ourselves to the technologies we have available in-house, we are happy to accommodate your particular approach or platform technology and will work with external parties.
To tackle the bioavailability challenges of your compound, our knowledgeable scientists will assess different formulations by developing discriminatory dissolution methods and by arranging comparative bioavailability studies. With their expertise, they can also devise a practical way to take one of these approaches forward to GMP manufacture.
Utilising our State-of-the-Art Containment Technology
We have designed, manufactured and installed state-of-the-art containment technology, to facilitate the processing of potent compounds in both our non- GMP and GMP pharmaceutical development facilities.
To contain airborne particulates, we have applied engineering solutions that employ rigid and flexible film isolator technology around the processing zones of equipment. Extensive dust monitoring exercises have determined the effectiveness of these containment solutions, demonstrating that we can process compounds with an occupational exposure limit as low as 50ng per m3.
For early phase development and manufacture, our Xcelodose® 600S systems include Xcelohood™ containment when filling capsules with API of high or unknown toxicity. We also have isolators and other containment technologies that enable us to handle potent compounds manually.
Facilitating the Ease of Transfer and Scientific Continuity
From a single site, Almac is uniquely able to provide a full range of scalable services, from non-GMP to GMP development, to clinical supply (Phase I – III) and into commercialisation.
Our development scientists work to advance robust formulations and processes which can be scaled-up and suited for large-scale commercialisation.