At Formex our scientists approach each formulation project with the end product in mind. The solutions we offer are tailored to your exact needs, with the primary objective of commercial success. We can engage at any point in the drug development process from earliest formulation development, dosage form optimization, clinical trial materials, through commercial manufacturing.
At Formex we utilize a variety of preformulation characterization approaches to select the right process and the best excipients for any formulation goal. We can perform chemical and physical characterization of the API, excipient compatibility, and small scale analytical and physicals tests that will help us rapidly make the right formulation and processing choices utilizing a minimum amount of API.
Our expertise covers a wide array of solid, liquid, semi-solid drug products, delivery techniques and therapeutic areas. Our experience includes the development of tablets, capsules (powders and liquid fill), powders for suspension/reconstitution, liquids, semi-solids, oral films, and more. Searching for creative solutions to pharmaceutical development challenges is a routine part of our work.
We have special expertise in developing dosage forms that improve the bioavailability of insoluble compounds through a variety of techniques to increase the solubility of the active. Making amorphous dispersions through hot melt extrusion or spray-drying, drug layering, designing emulsifying media, and particle engineering are all approaches we have used for our clients.
Tablet formulations are the most numerous and popular oral dosage forms. Formex has developed hundreds of tablet formulations, and can manufacture all such formulations under cGMP conditions.
From straightforward immediate release dosage forms generated by direct compression processes (API and excipients blended directly before tableting), to very sophisticated controlled release dosage forms with multiple functional coatings, and everything in between, our formulation scientists have provided successful tablet dosage forms for our clients.
As new technologies for dosage form manufacturing become common, such as HME and dispersions technologies, which generate novel drug intermediates, new challenges for incorporation of those intermediates into tablet formulations can arise. Formex has extensive experience in taking these novel drug forms, such as dispersions and extrudates, and developing processes that efficiently incorporate them into tablet formulations.
Capsules dosage forms can offer the most rapid route to preparing a drug formulation for clinical trial assessment. Small scale batch sizes of API in capsule or a simple formulation in capsule, can be quickly generated, with minimized analytical development, thereby driving rapid access to the clinic.
For later phase development requiring larger batches, capsules blends amenable to automated, high speed, encapsulation can be generated. Formex has proven successful experience in developing powder-fill, bead-fill, and tablet over-encapsulation capsule formulations. All formulations can be manufactured under cGMP conditions for clinical assessment.
In addition, utilizing liquid fill capsules can also provide an efficient and effective way to provide solubility enhancement for insoluble drugs. Oil, emulsion, or polymer-based solutions of insoluble API’s in hard capsules is a fast way to increase exposure of insoluble drugs for early phase clinical studies.
Semi-solids and Liquids
Formex has experience in the formulation and manufacture of a wide variety of liquid or semi-solid formulations. We have experience with developing clear solutions, gels, creams or lotions; both aqueous-based or organic-based.
We have developed liquids for oral use, which exhibit needed chemical stability and solution stability with appropriate taste-masked properties as needed. These formulations have been dosed as oral liquids or encapsulated.
We have also formulation many examples of topical dosage forms, including liquids, gels, creams, lotions, and ointments for topical use. We have successfully generated, chemically and physically stable formulations as clinical trial material.
Formex can develop the formulation, package the formulation as needed, and generate all supporting purity and stability data for these formulations.
Multiparticulate dosage forms, such a beads, microspheres, or engineered granules, can be used to provide a wide range of drug release patterns to meet an array of drug delivery needs. Multiparticulates can be designed to provide extended release, delayed release, pulsatile or bi-phasic release, or even site-specific release of drugs.
Beads can be made containing drug in a controlled release matrix, can be coated with release modifying polymer layers (such as enteric polymers or diffusion controlling polymers), or can serve as a substrate for drug-containing polymer coatings for drug-layering applications. Granules can be made from drug particles and binding polymers to generate modified release granules.
Multiparticulate formulations can have several advantages over single-unit controlled release dosage forms. They tend to exhibit more uniform gastric emptying as compared to single-unit dosage forms, which can be important for dosage forms with time-based release mechanisms. Multiparticulates also have significantly lower risk of dose-dumping than do single unit dosage forms, because the dose is distributed among many drug delivery units rather than being constrained to one unit. Multiparticulates also can provide more complex and customized release profiles, such as bi-phasic release using two populations of multiparticulates in a single dosage form.
Formex has the capability for bead manufacture through wet-mass extrusion and spheronization, and granule manufacture though high-shear granulation and melt-granulation processes. Beads and granules can be coated using aqueous- and organic based processes to apply functional and esthetic coatings. Beads can also be coated with drug-containing layers to provide certain release profiles, and to improve solubility through increased surface area of drug releasing particles: and to stabilize the drug in an amorphous form.
Clinical studies for candidate selection or first-in-man studies for initial safety evaluation often require simple dosage forms that require little time for development. API-in-bottle or API-in-capsule dosage forms that contain only the drug in a container meet these requirements. Not only is little development needed, but analytical methods developed for the API alone can often be used for analyzing the drug product as well.
Formex can also provide development of what we term “Fast Formulations” for early clinical studies. These are powder-in-capsule or powder-in-bottle formulations that can be quickly developed using a minimal number of excipients selected for function and non-interference with existing analytical methods. This approach provides the advantages of the API-in-capsule or bottle, while also providing a more robust formulation, capable of manufacture at a variety of scales with different equipment.