Tim Bretz’s Post

Pharmaceutical companies love to tout innovation but don’t always implement actual change. This is particularly true when it comes to innovation or change in their approaches to sterile packaging, delivery systems, or, ultimately, combination products comprising various components and constituent parts. The tendency is to stick with what has worked in the past. Doing so can seem to minimize risk and maximize efficiency. But does it? For more on this from Fran DeGrazio's Frankly Fran Column on Drug Delivery Leader click: https://lnkd.in/eCnbskUn #innovation #drugdelivery #combinationproducts

The majority of benign and malignant tumors thrive in a highly vascularized microenvironment. Tumors depend on existing or newly formed blood supply to receive oxygen and nutrients, making tumor vasculature an important conduit or “highway” for anticancer therapeutics. Thus, chemotherapies and other treatments can be administered systemically through the veins (intravenous or IV delivery) in order to reach the tumor site. However, hypovascular tumors have a paucity of blood vessels that feed into certain solid tumors. This characteristic of these tumors presents a challenge to deliver drugs systemically as adequate dose levels of effective therapeutics are limited from getting to target cells and most current chemotherapies have an already narrow therapeutic index (the delta between the efficacious dose and a toxic dose). For more on this, click below. #drugdelivery #oncology #tumors Shaun R. Bagai

Inhalation and nasal medicinal products include pressurized metered-dose inhalers, dry powder inhalers, medicinal products for nebulization, non-pressurized metered-dose inhalers, nasal sprays, nasal powders, and nasal liquids. Both nasal spray and inhalation products usually include a delivery device, and the site of intended action of the active ingredient may be local or systemic. These types of medicines are becoming more important given advantages they present over traditional dosage forms. Advantages include low first pass effect by hepatic metabolization, fast onset action, and high drug levels in brain tissue (via the nasal route) and lung (through oral inhalation). For more on this, click below: #drugdelivery #inhalation #nasaldelivery

Inhalable dry powder vaccines that can be administered via the pulmonary route have emerged as a promising approach. This approach offers many advantages, such as facilitating self-administration, eliminating cold chain requirements, and reducing logistical challenges associated with vaccine distribution. And this approach will be highly beneficial in arresting the virus at its port of entry, considering that the lungs are the primary site of COVID-19 infection.  For more on this, click below: #drugdelivery #covid19 #inhalation

The drug delivery device landscape is changing at a rapid rate: Drug administration by lay users (e.g., patients or caregivers) is becoming more common. Patients self-administering may have clinical manifestations impacting their ability to utilize a drug delivery device. Pharmaceutical companies are developing larger molecule, higher viscosity, and higher volume drugs that are more difficult to inject based on the force required for full dose delivery. We have been analyzing the progression of these factors, as well as the increase in FDA complaints for drug delivery devices that passed FDA approval but exhibit failures in the marketplace. We have determined that solely following FDA guidance may be insufficient for user success in the marketplace given the changing drug delivery device landscape. For more on this, click below: #drugdelivery #combinationproducts #fda #humanfactors

Drug Delivery Leader's Executive Editor Fran DeGrazio shares insights into Organizational Imperatives for Combination Product Development in this month's "Frankly Fran" editorial showcase. Fran touches on 3 key areas: Adapt to Regulatory Complexity Foster Cross-Functional Communication Manage Challenges With Oversight & Education If you're interested in reading more click here: https://lnkd.in/ePG_Dw7q #combinationproducts #productdevelopment

Outsourced Pharma and Singota Solutions collaborated to bring you this special edition newsletter focused on "Optimizing Aseptic Manufacturing Processes". If you're a pharma or biopharma company looking for a CDMO partner with available capacity who has the expertise to help you overcome regulatory hurdles, click this link to learn more: https://lnkd.in/eCcq7ktj #asepticmanufacturing #cdmo #capacity