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

  • 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

    To improve the suspendibility of a water- insoluble active pharmaceutical ingredient (API) in a sorbitol- based reconstitutable powder for oral suspension formulation using two novel excipients Sentry™Polyox™WSR N80, NF (polyethylene oxide) and Avicel CL-611® NF (microcrystalline cellulose/carboxymethylcellulose sodium).

  • 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.

  • How To Optimize Your Weighing Process
    How To Optimize Your Weighing Process

    Many factors found in the laboratory can influence the behavior of a balance. Learn how to anticipate and regulate them to achieve the ideal settings for your balance and the most reliable weighing results. By Michelle Sheridan, Sales Specialist, Premium Weighing Sartorius Corporation

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FORMULATION DEVELOPMENT PRODUCTS & SERVICES

Syloid® FP Silica Excipients Syloid® FP Silica Excipients

Syloid® FP silicas are the intelligent choice for many pharmaceutical applications due their unique morphology. The combined adsorption capacity, porosity, particle size, and greater internal surface area allow it to provide several benefits simultaneously that can help minimize the number of excipients required, expedite manufacturing, and improve efficacy of the final dosage form.

Powder Flow Tester (PFT) Powder Flow Tester (PFT)

AMETEK Brookfield's Powder Flow Tester delivers quick and easy analysis of powder flow behavior in industrial processing equipment.

NDA Approval And Post Approval Services NDA Approval And Post Approval Services

From 2006 through 2015, Patheon helped clients earn 92 NDA approvals. That’s  twice as many as any other CMO. Success brings more success at this stage. That’s because depth of experience, reliability of quality and refinement of processes are all important in the final push for regulatory approval and making the transition to commercial manufacturing.

Small Molecule Development And Manufacturing Services Small Molecule Development And Manufacturing Services

High-quality API via the development of a scalable process that will meet demand at each stage of your product’s life cycle. Complete drug product services from preformulation screening through clinical development to commercial supply. A comprehensive range of oral solid, sterile and softgel dosage forms with expertise in high-potency products. Unique solutions to overcome the toughest solubility challenges and accelerate your path to proof of concept.

Drug Product Development Services Drug Product Development Services

Considering that 90% of drug candidates have bioavailability issues, making sure your program is prepared for all phases of clinical trials from the very start is the fast way forward. Patheon Solubility Enhancement Services approaches BCS II and IV drug substance solubility issues a fundamentally different way that identifies the solubility enhancement technologies most likely to work before you get started. That helps eliminate rework and worry later on.

Low Temperature Benchtop Bath: CharpyCool Low Temperature Benchtop Bath: CharpyCool

The new CharpyCool is a mechanically refrigerated bench top bath that eliminates the need for costly consumables such as liquid nitrogen or dry ice. Compact and completely self-contained, the CharpyCool offers up to 8 liters of working fluid volume enabling up to 91 Charpy impact test specimens to be accommodated at temperatures between -80°C and +30°C. A powerful variable speed magnetic stirrer and vortex breaker provide excellent temperature uniformity and stability enabling superior results. PID control enables the CharpyCool to sustain precise temperature control to within ± 0.1°C. The CharpyCool includes a digital temperature display, and an optional Charpy Rack is available which allows multiple-specimen loading and easy access to monitor your testing.

Pharmaceutical Development Including Highly Potent Molecules

PCI provide CMC Consultancy services to generate the optimum development strategy for your product.

Used Accela 60” Coating Pan Used Accela 60” Coating Pan

One (1) used Thomas Engineering Accela Cota coating pan, model 60D, 60" diameter perforated pan, with spray guns, controls, serial# 60-847.

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