Our small but experienced staff works to advance and develop pharmaceutical technology for candidate compounds. Decades of success allow us to provide pharmaceutical formulations for all phases of drug development. We also provide experimental work, project management, and consulting services.

Equipment List

We find that the key to successful formulation is a thorough but targeted preformulation study. We will review your existing data in light of your desired dosage form, route of administration, and stage of development. We may recommend, if needed, additional preformulation studies so that the physiochemical properties of the drug molecule are adequately characterized. We perform the following studies through our preformulation services:

We take molecules that have been identified as drug candidates and formulate them for animal toxicological and/or efficacy studies with the idea that the data will form the basis of an IND or other regulatory agency equivalent submissions. We work closely with scientists so that the formula will be appropriate to the in vitro and/or animal efficacy model. Suspensions and solutions are common formulas for this early stage work, but we can provide almost any relevant dosage form with any route of administration in mind. Simple formulas that provide stability for the duration of the study are normally provided. They can either be made under normal laboratory SOPs or GLPs, depending on if the data will be submitted.

We develop formulations which allow for human trials using excipients suitable for human use. The excipients are chosen with regulatory acceptability for the route of administration. We work closely with regulatory groups to assure that the final body of work will lead to a successful IND filing.

Screening studies of prototype formulations are set up and monitored for physical and chemical stability. Surrogate tests of bioavailability may be monitored as well since these tests require development (i.e. dissolution, disintegration, and release rate). Some animal safety tests on these formulations may be required. Animal bioavailability, PK and TK tests may also be performed.

A prototype formulation is selected and optimized typically with an experimental design set up in packaging suitable for the clinical trial (may be more than one type), and adequate stability studies are conducted to allow for the clinical trial. Some animal safety studies on this formulation may be required and as a result, these lots are generally made under GLP. Data developed in this phase is incorporated into an IND or a similar document for other regulatory agencies.

Consequently, the phase 1 formula, specifications, test methods and manufacturing method are transferred to a cGMP contract clinical manufacturing facility. Our staff can manage and monitor the transfer of manufacturing and release if you desire. The packaged formula will be sent to a cGMP contract clinical labeler for study labeling. This batch is placed on stability and monitored for the duration of the study, and often longer.

Phase 2 formulations typically resemble commercial formulations. They are developed in a manner similar to the Phase 1 study formula, yet are usually consistent with final dosage form. Formulation screening, formulation optimization, package screening, and package selection must be done. Changes in API synthesis route and purification method may impact this process and need to be considered prior to initiating this phase.

During this stage, process studies are conducted to develop a robust and reliable method for manufacture.

Development of test methods and specifications are required; again, physical and chemical stability is monitored. Bioavailability is typically investigated in animal safety and efficacy models. Some animal safety tests may be required prior to testing on humans; thus, we perform GLP manufacturing on trial batches.

We are able to execute development work, then transfer Phase 2 formulas, specifications, and test methods to a cGMP manufacturing site for the production of clinical trial materials. Through our management, the materials would be packaged, labeled, and shipped to study sites either by the manufacturer, or more likely, by a contract clinical packager and labeler. Careful coordination, good communication, constant monitoring and attention to detail are keys to success.

The Phase 2 formulations require stability testing at least through the duration of the trial, but may have a complete shelf life stability test if the formula(s) and packaging are close to expected Phase 3 or commercial formulation.

Generally, Phase 3 formulations are derived from Phase 2 formulas. They are definitive formulas, and any changes subsequent to the clinical trial and prior to approval would usually require further clinical studies.

In a best case scenario, Phase 3 formulations are identical to the Phase 2 formula, and minor differences may center on packaging. For example, a 5 g tube may have been the primary package in Phase 2, but a 30 g tube is desired for the commercial drug product. In some cases, formulations may be optimized with minor changes such as viscosity, antioxidants, and preservatives. Less commonly, significant reformulation is required, and the screening and formulation optimization process must be repeated. Chemical and physical stability studies of the new or modified formula would be required prior to making any Phase 3 supplies.

As in Phase 2 studies, we coordinate the transfer of Phase 3 formulas, specifications, and test methods to a selected commercial cGMP manufacturing site for the production of clinical materials. The materials would then be packaged, labeled, and shipped to study sites by either the manufacturer or a contract clinical packager and labeler. We are able to manage this entire process for you. As in Phase 2, careful coordination, good communication, constant monitoring including being present for batches, and attention to detail are the keys to success.

PharmTak Contract Services handles the development of drug candidates from preclinical studies through commercialization. We are experienced in nearly all dosage forms and routes of administration.

Our services include: