Articles

51. Sterile Formulation And Fill/Finish For Early-Phase Clinical Trials Of Insoluble Drugs 1/28/2022

    Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges. In short, we consistently make the insoluble soluble.

52. Formulation Development Strategy For Early Phase Human Studies 1/27/2022

    Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.

53. Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway 1/26/2022

    Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.

54. Rational Design And Development Of Long-Acting Injectable Dosage Forms 1/26/2022

    The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.

55. Formulation Development From Preclinical To First-In-Human 1/24/2022

    A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.

56. Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway 1/24/2022

    Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.

57. Formulation Research Strategy For Discovery- Stage New Drug Candidates 1/24/2022

    Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.

58. Mitigating Hidden Risks: Extractables And Leachables 1/24/2022

    Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.

59. Crystallization Process Dev: Ramping Up Bench-Scale Control 1/20/2022

    Since physical structure and biological activity are directly linked, controlling the physical form of a compound is paramount to a final drug product’s quality and effectiveness.

60. Passive Needle Guard For Pre-Filled ISO Standard Glass Syringes 1/18/2022

    The BD UltraSafe Plus 2.25 mL Passive Needle Guard features an ergonomic design to help support injection comfort and ease of use.