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Formulation, Development & Delivery In-Depth Focus 2020
In this in-depth focus experts provide guidance on how to select starting materials for API's and discuss how to specify exipients to reduce downstream regulatory burdens.
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Formulation
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European Pharmaceutical Review Issue 5 2020
In this issue you can find articles discussing the supply chain implications of Trump's 'Buy American' order, guidance on how to identify and justify starting materials for regulatory approval by both the EMA and FDA, as well as some of the latest developments in oral biologic drug delivery techniques. Also…
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First patient dosed in COVID-19 vaccine tablet clinical trial
A Phase I clinical trial to test VXA-CoV2-1, an oral tablet COVID-19 vaccine candidate, has been initiated with the first patient dosed.
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Team enhances bioavailability of simvastatin with mucoadhesive buccal films
Researchers have shown that mucoadhesive buccal films containing simvastatin inclusion complex and drug mixed micelles can improve the drug's bioavailability.
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Dolutegravir plus lamivudine shows non-inferior HIV-1 suppression in Phase III trials
Dolutegravir plus lamivudine was as effective at suppressing HIV-1 in adult trial participants as a three-drug regimen, dolutegravir plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC).
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Using rafts to enhance bioavailability of ibandronate
Researchers have developed a novel tablet formulation of ibandronate which increases the oral bioavailability of the drug by releasing it from a hydrogel raft formed in the stomach.
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Whitepaper: How will COVID-19 accelerate vaccine development?
Watson-Marlow Fluid Technology Group discusses how the biopharma community is coming together to solve the global vaccine development challenge.
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Phase I trial of intranasal COVID-19 vaccine spray approved in China
A Phase I clinical trial to test an intranasal COVID-19 vaccine spray has been given regulatory approval in China and is expected to begin in November.
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Oral antibiotics effective at killing P. aeruginosa in cystic fibrosis patients
A clinical trial has shown that antibiotics administered orally are just as effective at killing Pseudomonas aeruginosa in cystic fibrosis patients as intravenous antibiotics.
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Oral COVID-19 vaccine candidate to enter Phase I human trials
Vaxart's application for a Phase I clinical trial to evaluate its oral COVID-19 vaccine candidate has been cleared by the FDA.
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Whitepaper: Considerations in support of achieving successful double blinding and removing bias with over encapsulation
This whitepaper explores critical factors for over-encapsulation success. DBcaps® capsules offer a convenient option for blinding in clinical trials.
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COVID-19 vaccine tablet induces systemic and mucosal immune responses
The researchers suggest inducing a mucosal immune response may be crucial to protect against SARS-CoV-2 infection and that the tablet formulation could overcome several major challenges associated with injectable vaccines.
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Cannabinoid series: growing and extracting APIs
Michael Sassano from Somai Pharmaceuticals and Solaris Farms discusses the US and European markets for growing and extracting cannabinoids for the pharmaceutical industry.
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Russia’s Sputnik V COVID-19 vaccine safely elicits an antibody response, reports paper
Preliminary data from Phase I/II trails evaluating the vaccine reveal 100 percent of participants had a humoral and cellular response, with no serious adverse events reported.
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Whitepaper: Characterising insulin as a biopharmaceutical using Analytical Ultracentrifugation
AUC was used to probe the effect of insulin concentration and the zinc chelating agent EDTA on monomer, dimer, and hexamer formation of USP Human Insulin Standard.
