Formulation Development
Formulation development refers to the evaluation of different excipients and stability profile using a series of analytical techniques.
Pharmaceutical companies need to perform the formulation development efficiently to enable their drug's bioavailablity, at the right rate, and ensure the compound is stable with a scale-able process to move through clinical trials to commercial launch. BOC Sciences has over 30 years of experience in developing formulations across a variety of indications. With expertise in simple and complex dosage forms and a unique track record in clinical studies, we know what formulations need to be developed throughout the development process. Our formulation team has the ability to develop new solutions and implement them in a timely manner according to predefined specifications.
Figure 1. The Future of Formulation Development with Melt-based 3D Printing Technologies
Our Services
To make it easier and better for researchers, BOC Sciences provides formulation development service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs. With state-of-the-art facilities and highly experienced formulation and analytical scientists, BOC Sciences is committed to providing comprehensive and tailored formulation development services
- Data-driven decision making coupled with years of formulation expertise to meet therapeutic and delivery needs to deliver API to its target
- Based on the physicochemistry and biopharmaceutics properties of your molecule, we are able to perform the optimization from preclinical and first-in-human dosage forms to develop your drug products for late stage development and market
- By applying advanced taste masking strategies which is developed based on formulations that function at the molecular level to create a barrier between API & taste buds, we can deliver sophisticated taste masking solutions for 95% of all oral dosage forms
With nearly 30 years of experience, our expert team has established a broad range of technologies and formulation approaches to address these complex solubility challenges. Our strategies allow us to dramatically speed up the optimization of your drug products to improve oral bioavailability
An comprehensive understanding of API stability is helpful in informing the ICH stability study. BOC Sciences therefore recommends that a formal stability study is carried out as soon as material is available from the developed synthesis
Lyophilization Stability Enhancement
Clients from around the world enlist our lyophilization expertise to assist with the pharmaceutical manufacturing of investigational bulk lyophilization APIs. Whether you are developing liquid or lyophilized dosage forms, BOC Sciences ensures speed and flexibility of your project development. We are capable of screening multiple experimental formulations simultaneously to expedite the formulation development phase of your project and get you to the lyophilization step
Figure 2. QbD approach for formulation development. (Bhattacharyya, S.; Adhikari, H.; et al. 2019)
Dosage forms development
BOC Sciences' formulation group specializes in the development of a broad range of dosage forms:
Oral formulations and dosage forms
- Solution, Suspension;
- Tablet: Immediate/control released tablet, Oral disintegrating tablet, Chewable tablet, Effervescent tablet, Bilayer tablet, Mini-tablet
- Capsule: liquid, powder, granules, pellets, and/or tablets in hard gelatin or HPMC capsule
- Particulate: Single or combination of multi type of particulates
- Drug in bottles or in capsules
- Powder blend in bottles or in capsules
- Powder in Sachets
- Enteric drug delivery
Injectable formulations and dosage forms
- Solution
- Suspension
- Microemulsion; Nanocrystal
- Complexation
- Microsphere
- Lyophilization powder
- In-situ gel
Figure 3. Types of formulation work being sourced. (Xiaorong, H.; Ajit, N.; et al. 2011)
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of formulation development at competitive prices for global customers. Personalized and customized services of formulation development can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
References
- Shaping the Future of Formulation Development with Melt-based 3D Printing Technologies. Pharma Excipients. 2020.
- Bhattacharyya, S.; Adhikari, H.; et al. A brief review on Qbd approach on liposome and the requirements for regulatory approval. Research Journal of Pharmacy and Technology. 2019. 12(8): 4057.
- Xiaorong, H.; Ajit, N.; et al. Formulation development roundtable. Pharmaceutical Outsourcing. 2011.
