Formulation Service

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Pharmaceutical formulation is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. Development of novel dosage forms such as capsules, tablets, oral solutions, suspensions and syrups has become an important current focus for pre-clinical safety evaluation within the pharmaceutical industry. BOC Sciences has significant experience performing risk assessments and subsequent statistically designed experimentation for understanding the parameters and quality attributes that impact the clinical performance and safety of formulations, manufacturability of dosage forms, and stability in primary packaging.

BOC Sciences provides wide range of services such as, formulation development, scale-up process (up to 50 kg batch size), stability study, CMC document for registration (IND) and cGMP facility for CTM manufacturing (Phase I and Phase II). Pre-formulation studies in combination with analytical methods are critical to identifying the best formulation strategy for a compound. Certain candidates present specific challenges such as poor solubility, low bioavailability and/or permeability and poor physical stability. Formulation development can be helpful in overcoming many of these issues.

Dosage forms include:

  • • Solid dosage formulations (capsules, tablets for immediate release or extended release)
  • • Semi-solid formulations for oral administration (syrups, suspensions)
  • • Sterile liquid dosage formulations (ophthalmic, oral, nasal)
  • • Lyophilized formulations
  • • Topical formulations (creams, gels)
  • • Transdermal patch

Preclinical formulation development for small molecules and peptides:

  • • Purity determination, Hygroscopicity studies and Physicochemical characterization
  • • Solubility and pH-rate profile, Polymorph screening and Salt form selection
  • • Particle size distribution, Excipient compatibility and Stability evaluation
  • • Peptide chemical stability
  • • Early formulations for PK, PD and toxicological evaluation

Early phase development:

Our non-GMP facility focuses on lab-scale experiments, with batch sizes ranging from < 2kg up to a maximum of 20 kg scale for most technologies. Our GMP facilities support drug product manufacturing in phase I and phase II.

Our non-GMP facility provides the transition between development and GMP phases of projects in early stage pharmaceutical development. We can conduct non-GMP work efficiently and transfer quickly to GMP manufacturing by deliberately ensuring good integration of all technologies in both the non-GMP and GMP facilities, which will essentially speed up your overall project timeline.

Early phase development:

The most common approach in early phase development is to develop a relatively simple formulation using common pharmaceutical excipients. We believe in Quality-By-Design (QBD) therefore when we develop blending, granulation processes or roller compaction we always keep an eye to the future to ensure that your formulation can be scaled up for later stage clinical development.

At BOC Sciences, we can quickly fill small quantities of capsules by hand or using capsule boards. We also have automated technology precision powder micro-dosing system.

Late phase development and manufacture:

At BOC Sciences, we have lots of experience to develop robust formulations and manufacturing processes which will enable confidence and security in the supply chain. We have assisted many of our customers in developing both immediate and modified release formulations for their late phase clinical trials, registration batch manufacture and also commercial launch.

For different stages of manufacture we could offer the following technologies ranging from hundreds of grams for initial formulation development to hundreds of kilograms for phase III/IV and registration batch requirements:

  • • Dry Powder Blending and Roller Compaction
  • • High Shear and Fluid Bed Granulation
  • • Spray Drying and Pan Coating
  • • Encapsulation – Single and Combination Doses of Powders, Pellets & Tablets
  • • Tabletting – Single Layer, Bi-Layer and Compression Coating / Tab-in-Tab Formats
  • • Fluid Bed Coating, Wurster coating and Patch Manufacture

Quality by Design (QbD)

The ICH Q8 guideline states that quality should be built in by design instead of tested into products. BOC Sciences focuses on using the QbD approach on every single batch of our product. Design of Experiment (DOE), Risk Assessment Tools (RAT), Process Analytical Technologies (PAT) are employed all along in the lifecycle of our formulation development to improve the quality, safety and efficacy of drug product:

  • • Determine the Quality Target Product Profile (QTPP) of the specific product
  • • Identification of the Critical Quality Attributes (CQAs) of the drug and the Critical Process Parameters of the process
  • • Potential formulation strategy suggestions with QbD Principles
  • • Conduct the Preliminary Risk Assessment
  • • Analyze the risks of the selected CQAs and CPPs for each unit operation
  • • Chose the appropriate control strategies for selected CQAs and CPPs
  • • Establish the Design Space

Instrumentation:

  • • High shear mixer
  • • Fluid bed dryer
  • • Tablet press
  • • Bi-layer Tablet press
  • • Coating pan
  • • Extrusion-spheronization
  • • Spray dryer
  • • Jet mill for micronization
  • • Nano mill for nano size particles
  • • Homogenizer
  • • Blister packaging
  • • HPLC
  • • Stability chambers
  • • Patch Manufacture

Find out more about how we can help you develop the best formulation strategy for your drug and speak to our experts. Please contact us directly to learn more about this enhanced service.

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