Formulation Development

Formulation Development
Formulation development is essential for optimising drug performance, ensuring patient safety and compliance, and meeting regulatory requirements in the pharmaceutical industry. It is a critical aspect of the drug development process that requires interdisciplinary expertise in pharmaceutical sciences, chemistry, engineering, and regulatory affairs. PharmSky Research can help turn your drug into an effective formulation that meets patient needs and provides the intended product performance. From beginning to end we follow the ICH Q8, 9 and 10 guidelines, to ensure delivery of a robust product and a manufacturing process which performs consistently and meets all suggested requirements for 3.2.P.2 and 3.2.P.3 submission. This can include the following stages:

Working closely with the client, we will develop a target product profile (TPP) that meets their requirements. By carefully considering all available information, we will identify the most promising formulation options and produce laboratory batchs to obtain stability data. Stable lab batches appropriate for pre-clinical studies and pilot scale batches suitable for First-in-Human (FIH) clinical trials can then be manufactured.

Based on stability data of up to 4 weeks or as required by the client, PharmSky can produce, label and pack clinical trial material (CTM) in our phase I facility. We can then ship to the FIH clinical sites as per the client’s instructions. PharmSky has the ability, skills, and quality systems to support rapid formulation development for FIH trials. We will meet your requirements and efficiently deliver your FIH trial material on a swift timeline.

Formulation optimisation for clinical trials and potential commercial products. After completion of a FIH trial, in alignment with client’s feedback, PharmSky will consider the critical quality attributes (CQA) of the product with respect to the TPP. Based on these attributes, we will work towards optimising the overall design of the formulation, aiming to improve the stability of the formulation such that is suitable for later clinical phase I, II or III trials. Utilising Quality by Design (QbD) tools such as Design of Experiments (DoE), we can conduct multivariate screening and optimisation studies to identify the most important material attributes and process parameters, and ensure readiness for further scale up.

During this stage, PharmSky can source container suitable for the client’s needs and initiate stability studies in these container/closures to ensure compatibility and verify that there will not be extractable and leachable concerns . The extent of this stage can be tapered depending on the clients’ requirements.

As the product moves towards later stage clinical or commercial manufacture we can work with the client and their proposed manufacturing site to scale up and transfer the manufacturing process. The entire product life cycle can be risk assessed and a viable formulation and manufacturing design space established to ensure the process repeatably produces a robust finished product. The data generated at PharmSky from process development, scale up and tech transfer can be used for your final product registration if required.

PharmSky Research specialises in developing formulations for a wide range of dosage and delivery forms including the following:

PharmSky scientists have decades of experience in development and registration of both simple and complex aqueous and non-aqueous sterile injectables for global markets. This includes lyophilised formulations and the associated process development.

We understand the complex regulatory space sterile injectables inhabit and will help you carefully navigate this space to ensure production of a stable product.

Challenges commonly encountered in injectable formulation development include meeting concentration and solubility requirements, water insoluble drug substances, drug substance susceptibility to oxidation, hydrolysis or photodegradation , container closure selection and leaching from such, particulate matter contamination, scale up, in-use stability and sterilisation method identification. If you need assistance in any of these areas, PharmSky will be able to help you.

Difficulties confronted in topical formulation development include ensuring adequate skin permeation, formulation stability, irritation/sensitisation caused by excipients, dosage uniformity and preservative selection. Following our formulation development processes, we will help you overcome these and ensure that ideal excipient combinations are selected to produce a stable, efficacious product, be it a cream, ointment or gel. We can also work with you to develop suitable analytical methods to assess skin permeation and chemical, physical and microbiological stability.

Nanoparticle formulations such as liquid emulsions, liposomes and polymeric and lipid nanoparticles can help overcome solubility, toxicity and degradation issues. However, developing formulations of this type is fraught with risk. The added complexity can quickly lead to stability, scale-up and/or regulatory issues. To avoid these, it is best to work with a company experienced in navigating these challenges such as PharmSky.

Up to 90% of drugs in the development phase and 40% of marketed products exhibit poor aqueous solubility. Therefore, the ability to successfully develop formulations for poorly water-soluble drugs has become essential. Many newly proposed or investigational drugs suffer from water solubility issues, presenting major hurdles to the design of suitable formulations that can be safely administered to patients.

At PharmSky, we have years of experience in the development of techniques and formulations to overcome aqueous solubility hurdles. We can help you develop formulation strategies for hydrophobic drugs, with options such as the use of liposomal formulations, cyclodextrin carriers, solid lipid nanoparticles, nano or microemulsions and co-solvent systems considered. Completion of pre-formulation studies including solubility studies and solid-state characterization of API can be used to support formulation development. Our team are also experienced in scaling up and addressing the regulatory issues associated with hydrophobic drug formulations and delivery systems.

Depot formulations are used to prolong the release of an active compound, thereby reducing the frequency of dosing and improving patient compliance. If you have a product that would benefit from this, PharmSky can recommend and test a range of different gelling and/or particulate options to meet your desired target product profile. We are experienced in overcoming the complexities of this process, designing robust formulations, and developing models for drug in vitro/in vivo release to understand product behaviour following injection.

From simple generic copies of existing formulations to complex products which improve upon these by utilising the technologies above, PharmSky can help you bring a high-quality generic to market quickly and safely. If you have a generic you want to develop, get in touch and we can explore your options.

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