Late Stage Formulation Development

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Late Stage Formulation Development

The availability of high quality formulations that are designed to achieve therapeutically-relevant pharmacokinetic drug profiles has a pivotal role in determination of the safety and clinical efficacy of medicines. The pharmacists and pharmaceutical scientists at BOC Sciences are dedicated to facilitating access to safe and efficacious medicines.

Seamlessly transfer of the knowledge which are gained during late stage of formulation development to commercial-scale pharmaceutical manufacturing can be ensured by our experienced drug formulation development expertise. BOC Sciences has highly strained work teams and a wide array of sophisticated techniques to help you successfully develop and commercialize pharmaceutical products in semi-solid and liquid dosage forms. As professionals in commercial pharmaceutical manufacturing processes, our scientists have the art equipment for efficient and scalable formulation and manufacturing processes at their disposal.

Lead prototype identification

Identification and optimization of the lead prototype have been recommended as one of the most important steps in drug development. Our chemists have profound expertise in analyzing the chemical structure of the lead compounds and the linkage between the physicochemical properties and the potential pharmacological activities. Based on the collected data of ADMET (Adsorption, Distribution, Metabolism, Excretion and Toxicity), our experts can provide you the better quality of lead molecules by further optimization.

For drugs to be effectively delivered to patients, all pharmaceutical products should be formulated to specific dosage forms. The routine pharmaceutical dosage forms consist of tablets, capsules, solutions, suspensions, topical ointments, gels and injections for intravenous/intramuscular (IM)/subcutaneous. During the development of a drug formulation, various factors including Manufacturability, product shelf life, bioavailability and the chemically and physically stability should be taken into significant account. According to the properties and action sites of your drug substances, scientists of BOC Sciences will fabricate different dosage forms by the corresponding pharmaceutical technologies. Importantly, to ensure the efficacy and safety of your end products, the formulation design and screening will be conducted under a wide array of quality standards and special requirements.

In general, there will be multiple manufacturing processes which can be applied for producing a given product. However, it is necessary to choose the most suitable manufacturing route for achieving the goal of economically and efficiently commercialized production. By working with a highly efficient work flow and basing on the product design, our experts will guide you through the selection process. The manufacturing process of your products will be optimized according to the following items:

Quantity of the productQuantity of the product>
Cost for manufacturing equipmentProcess supervision
Time required for processingEnergy consumption
Level of skilled labor requiredAvailability and cost of material
Capabilities required to processes materialProduct dimensions and size
Surface finish requiredMaintenance costs
Design tolerancesWaste produced by the process

As freely accessible to a wide range of top-notch technology platforms, scientists of BOC Sciences have the great capability of scaling-up many kinds of products. With deep understanding of the pivotal role of scaling factors and discrete activities, the process will be de-risked and manufacture the goal with robust cost effectiveness. More importantly, our experts will collaborate closely with you to ensure the technology success and knowledge transfer.

We have the unique advantages as follows:

  • Integrating the unique testing and scale-up facilities with practical experience
  • Flexible lab to pilot scale equipment sets
  • Allowing clients to integrate their own apparatus for evaluation
  • Identification of the best routes with our scale up activities

Knowing that efficient, low-cost and timely production of your high quality products compose the core competitiveness of your company, our experts will work abiding by the QbD principle to optimize a variety of key process parameters covering blend, granulation, formulation and scale-up. Quality by Design (QbD), the science- and risk-based approach launched by the US Food and Drug Administration, has been widely applied in the pharmaceutical industry for its great capacity of modernizing pharmaceutical manufacturing and improving product quality. Our scientists have a profound understanding of the signal effect of QbD in the development of late-stage drug products. Utilizing a wide range of analysis methods and techniques, we will offer you a comprehensive report and systematic approaches for strengthening the specifications and manufacturing ranges.

BOC Sciences the ability to offer the clients with various scale of batches manufacturing to meet the requirements of stress stability testing.

  • Small scale of batches manufacturing
  • Medium scale of batches manufacturing
  • Large scale of batches manufacturing

Reference

  1. (2005) ‘Design of Experiments for Formulation Development’. Pharmaceutical Technology, 2005(7).
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