Formulation Development

FORMULATION DEVELOPMENT WHITE PAPERS & ARTICLES

  • 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.

  • Which Laboratory Software Is The Right One For Your Lab?
    Which Laboratory Software Is The Right One For Your Lab?

    “Why do you need this laboratory information management system (LIMS)?” “We have an enterprise resource planning (ERP) system, why do we need to purchase yet another software product?” “How will the system you’re recommending improve lab operations?”

  • 4 Questions To Guide Your Laboratory Centrifuge Selection
    4 Questions To Guide Your Laboratory Centrifuge Selection

    A centrifuge is an integral component of a laboratory that is critical to the success of an analysis. They come in a variety of sizes, from mini-centrifuges that hold only a few small tubes and spin a few thousand RPM to high capacity centrifuges that hold up to 6 liters of samples to ultracentrifuges that spin upwards of 100,000 RPM. Multiple options in size as well as other areas can make choosing the right centrifuge for your application an overwhelming task.

  • Scientific Advances Address Challenges Posed By Poor Solubility Of Drug Candidates
    Scientific Advances Address Challenges Posed By Poor Solubility Of Drug Candidates

    At Metrics Contract Services, Dr. Michael DeHart manages all aspects of personnel and operations relating to formulating and manufacturing a client’s pharmaceutical materials for Phase I, II and III clinical trials. In this article, Dr. DeHart discusses how scientific advances are addressing challenges posed by the poor solubility or stability of drug candidates.

  • How Broadening The Analysis Of Compound Factors Allows For Predictive Solubility Solutions
    How Broadening The Analysis Of Compound Factors Allows For Predictive Solubility Solutions

    The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process, helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing. The objective of the BCS system is to predict in vivo performance of drugs from in vitro measurements of solubility and permeability. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability.

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FORMULATION DEVELOPMENT APPLICATIONS & STUDIES

  • 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

  • A Mesoporous Silica Carrier Optimized For Liquisolid And Lipid-Based Formulations
    A Mesoporous Silica Carrier Optimized For Liquisolid And Lipid-Based Formulations

    Syloid® XDP silicas are mesoporous, amorphous, silica gel excipients with a unique morphology that create an excellent solid porous carrier for pharmaceutical formulations. The combined adsorption capacity, porosity, particle size, and density provides a tool to create formulations which can expedite manufacturing and improve efficacy of the final dosage form.

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FORMULATION DEVELOPMENT PRODUCTS & SERVICES

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.

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.

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.

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.

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).

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

CR22N High-Speed Refrigerated Centrifuge CR22N 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.

Used Pharmacia Biotech Chromatography Column Used Pharmacia Biotech Chromatography Column

One (1) used Pharmacia Biotech chromatrography column, column type 450V-200-400, stainless steel product contact surfaces, 31.8-63.6 lier capacity, rated 3 bar at 2 - 30 C, serial# 450V-EQ434-01, with pump cart with (2) 1" poly diaphragm pumps, vessel certified by Mann Welding, rated 45 psi and full vacuum at 100 F, on cart, serial# 1778, national board# 1364, built 1997.

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