Formulation Development

FORMULATION DEVELOPMENT WHITE PAPERS & ARTICLES

  • Merck’s Path To Continuous Manufacturing For Solid Oral Dose Products: What Stands In The Way?
    Merck’s Path To Continuous Manufacturing For Solid Oral Dose Products: What Stands In The Way?

    As the evolution of the global pharmaceutical industry continues to drive the need for more flexibility and lower costs, continuous manufacturing becomes an even more appealing and sensible option. However, despite the tremendous promise of its economic and quality control benefits, there are still many concerns about the regulatory landscape for continuous manufacturing. Dr. Christine Moore, executive director and global head of chemistry, manufacturing and control (CMC) policy at Merck, recently discussed the company’s pursuit of worldwide approval of continuous manufacturing for solid oral dosage products and what regulatory risks it sees as potential roadblocks.

  • Introduction To Solvent Evaporation
    Introduction To Solvent Evaporation

    Solvent removal is an essential process for sample preparation across a range of applications in many industries. Many sample formats and solvents are used with no single technique providing a universal solution, but despite the variety of specifics evaporation is well-understood and relatively uncomplicated. But while evaporation is an intrinsic step in so many applications it’s rare to find an evaporation expert in a laboratory, and many facilities use systems that are slow and cumbersome simply because they have always been used.

  • Avoid Tablet Production Problems In The Formulation Development Process
    Avoid Tablet Production Problems In The Formulation Development Process

    Compression tooling and tablet press manufacturers are faced with ongoing challenges in the tablet manufacturing environments. Providing support in all aspects of the tablet compression process should be expected from your tooling and tablet press partner. These services should include: press operator training, maintenance/calibration services, quick delivery of replacement parts, tooling, tablet design and powder formulation support.

  • Successfully Transforming From CMO To CDMO
    Successfully Transforming From CMO To CDMO

    CMOs are now providing more early development support to their customers as well as offering fully integrated services, including specialized services such as aseptic fill-finish. Growth of the full-service contract development and manufacturing organization (CDMO) market has enabled a paradigm shift from early biotechnology companies that wanted to become “fully integrated pharmaceutical companies” to today’s nimble, lean, and sometimes virtual companies.

  • Is your Complex Formulation Process Set Up for Success?
    Is your Complex Formulation Process Set Up for Success?

    This article discusses six major types of complex formulations as well as the important equipment and processes necessary to develop GMP-compliant processes.

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FORMULATION DEVELOPMENT APPLICATIONS & STUDIES

  • True Scientific Knowledge Management In R&D: Electronic Laboratory Notebooks (ELNs)
    True Scientific Knowledge Management In R&D: Electronic Laboratory Notebooks (ELNs)

    One tool holds a unique position among R&D informatics systems. Unlike other systems, electronic laboratory notebooks (ELNs) both produce data and consume information. An ELN’s ability to capture data, observations, experiences, and context is particularly powerful when combined with other data pipelining tools. The ability to link key pieces of data and mine experiments captured in the ELN for insights fuels true scientific knowledge management. This use case describes the broad organizational benefits that BIOVIA Workbook made possible for a global pharmaceutical company, highlighting how the system is supporting efforts to gain predictive control over key processes in Research and Development.

  • Pharmaceutical Powder Flow Characterization: Small Volume Testing Needed
    Pharmaceutical Powder Flow Characterization: Small Volume Testing Needed

    There is a saying: Go big or go home. But not when dealing with sample testing of pharmaceutical powders. Then the saying is: Waste not, want not. In the cutthroat world of Big Pharma, staying one step ahead of the competition is imperative. Research to create the next new drug is a costly endeavor. Once a new product is developed, speed to market is the next challenge.

  • How A Placebo Formulation Is Designed For An Oral Solid Dose Product
    How A Placebo Formulation Is Designed For An Oral Solid Dose Product

    To demonstrate the process by which a placebo formulation was designed for an oral solid dose product that would be dispensed to the patient as a fast-dissolve tablet.  The tablet is added to water and the resulting solution is dosed as a antibiotic mouthwash.   Placebo matching was required not only for the tablet but also for the solution which the patient took.

  • Improving Suspendibility Of A Water-Insoluble API For Oral Suspension
    Improving Suspendibility Of A Water-Insoluble API For Oral Suspension

    In this case study, API (X) is a highly insoluble compound with a particle size of approximately 14 microns and targeted as a powder for oral suspension dosage form.

  • Predicting The Fate Of Crosslinked Gelatin Capsules In Gastrointestional Milieu
    Predicting The Fate Of Crosslinked Gelatin Capsules In Gastrointestional Milieu

    To observe, using carbon-13 nuclear magnetic resonance (13C-NMR), the effect of dilute acid and pepsin on gelatin crosslinks, induced by addition of 13C-enriched formaldehyde (13CH2O) to an aqueous gelatin solution.

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FORMULATION DEVELOPMENT PRODUCTS & SERVICES

Used  365 LCMS/MS SCIEX Mass Spectrometer Used 365 LCMS/MS SCIEX Mass Spectrometer

One (1) used SCIEX API mass spectrometer, model 365 LCMS/MS.

Benchtop Centrifuges Benchtop Centrifuges

NuAire benchtop centrifuges offer mono and multi functionality, refrigerated and non-refrigerated models. Technical innovations optimize productivity in your laboratory work to improve results, save time, while providing a greater relative centrifugal force (RFC).

High-Speed Refrigerated Centrifuge High-Speed Refrigerated Centrifuge

The Hitachi Koki model himac CR22N High-Speed Refrigerated Centrifuge offers reliable performance with a maximum RCF of 55,200xg and capacity of 6L for bottles, tubes, or microplates. Patented features such as the Automatic Rotor Identification and Rotor Cover Detector make the CR22N the ideal separation tool for multiple research applications involving DNA, RNA, viruses, proteins, and more

Ultracentrifuge Ultracentrifuge

The CP100WX is a general-purpose Ultracentrifuge with outstanding performance up to 100,000 rpm assisting in a wide range of separation protocols in involving proteins, DNA, RNA, metal nano-colloids, and more. Reliable and efficient the Hitachi CP100WX features a Rotor Life Management (RLM) system to automatically maintain rotor logging history maximizing rotor life.

Micro Ultracentrifuges Micro Ultracentrifuges

NuAire is pleased to partner with the reputable brand Hitachi Koki to offer our customers sales and support of table top and floor standing Mirco Ultracentrifuges in the North American market.

Microcentrifuge Microcentrifuge

NuAire offers ventilated and refrigerated micro-centrifuges ideal for high and low speed applications for small sample volumes.

Mini Microcentrifuge  - Prism™ LN-C1801 Mini Microcentrifuge - Prism™ LN-C1801

The user-friendly Prism™ Mini is a reliable, compact, and economical personal microcentrifuge ideal for quick spins that can be used for a wide range of molecular biology protocols. Prism™ Mini works out of the box with a maintenance-free drive system and advanced design providing quiet operation and proper ventilation protecting temperature-sensitive samples. Prism™ Mini includes two (2) quick release interchangeable rotors with a max speed up to 6000 RPM.

Laboratory Centrifuges Laboratory Centrifuges

NuAire benchtop centrifuges offer mono and multi functionality, refrigerated and non-refrigerated models. Technical innovations optimize productivity in your laboratory work to improve results, save time, while providing a greater relative centrifugal force (RFC).

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