| API SYNTHESIS & MANUFACTURING |

Adapting APIs for Specialty Dosage Forms

Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.
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| FORMULATION |

Avoiding Bitter Taste

Palatability is crucial for adherence and compliance to oral drug regimens.
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| ANALYTICS |

Residual Moisture Determination in Lyophilized Drug Products

The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.
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| MANUFACTURING |

Advancing Transdermal Drug Delivery

PATH’s Microarray Patch Center of Excellence aims to accelerate transdermal patch technology for public health needs.
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The Emergence of Operational Technology as a Service

The pressure to improve operational technology performance combined with the rapid pace of technology change is driving adoption of new automation models in pharmaceutical manufacturing.
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| QUALITY/REGULATIONS |

Evaluating the Tech Transfer Process

Unforeseen challenges can be avoided in technology transfer by evaluating the variety of processes involved.
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QbD Takes Shape for Topical Pharmaceuticals

As they seek to increase the number of generics available, regulators are requiring that in-vitro and other test data be used for ANDAs, and promoting the concept of biowaivers that would allow such data to replace costly clinical studies.
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| OUTSOURCING |

Developments in the Pharmaceutical Outsourcing Industry

Contract manufacturers are making strategic partnerships and expanding services in the last quarter of 2019.
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| PEER-REVIEWED RESEARCH |

Optimizing Compression Coating for Pulsatile Release Tablets

Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis.
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| FROM THE EDITOR |

Breaking the Drug Shortage Cycle

FDA report says drug shortages are underappreciated and patients pay a price.
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| US REGULATORY WATCH |

More Consistent Drug Inspection System on Horizon

FDA readies more efficient oversight processes while advancing collaboration with Europe.
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| ASK THE EXPERT |

Signatures-What’s in a Name?

It is good industry practice to clarify the precise remit for each of the reviewers of a controlled document, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
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