Get more pharma manufacturing insight with our FREE newsletter sign me up

INSIGHTS ON SOLID DOSE MANUFACTURING

SOLID DOSE MANUFACTURING SOLUTIONS

  • Basic Powder Flow Characterization [USP <1174>]:

    A powder flow analysis is an indicator of how well formulation will release from the hopper during the tableting. It is important to know that the developed formulation is showing ‘Mass Flow’ or ‘Funnel Flow’ or ‘Rat Holing’.

    Powder blend shows ‘Mass Flow’ when the entire solid bed is in motion during the discharge of material from the outlet. This is a ‘First-in-First-Out’ process. Hoppers offering ‘Mass Flow’ have steep and/or low-friction walls. This flow offers ‘No-Arching’, ‘Less Segregation’, and ‘Stable Powder Flow’.

    When the hopper is not sufficiently steep and smooth enough to ensure sliding along its wall, the powder blend exhibit ‘Funnel Flow’. Such hoppers are sensitive to arching and ratholing. In this case, powder discharge from the hopper is not predictable.

  • Used Sejong Encapsulator, with change parts/tooling, 600 volts, 3 phase.

     
  • Hata Tablet Press, Model HT-AP55-DU/I.E. Double sided, serial number Nov. 90 - Oct. 1991

  • Partner with Natoli Scientific during the earliest stages. Our scientific expertise with state-of-the-art analytical capabilities is ready to take any preformulation challenge.

    Natoli scientific has an expertise of handling a wide range of APIs for the development of oral solids. We apply principles of ‘Quality by Design’ to define Critical Material Attributes (CMA), Critical Process Parameters (CPP), Critical Quality Attributes (CQA) and Quality Target Product Profiles (QTPP). Because we believe that understanding material and process as much as possible in the early life cycle of drug product development program is an insurance for further development path. Keeping your practices up to date with the ICHQ8 regulatory guidance issued by the US FDA. This is also a gate way for a smooth ride of product in the different stages of product development stages.

  • Finding a strategic CDMO partner that will offer tailored solutions for your late phase clinical and commercial needs, mitigate risks, and bolster your supply chain is crucial for meeting project milestones on time.