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Solvent
Nitrosamine Risk Assessments in Oligonucleotides
The European Medicines Agency, the U.S. Food and Drug Administration, and other regulatory agencies expect that all pharmaceutical products be assessed for the potential presence of N-nitrosoamine (nitrosamine) impurities. This white paper addresses general considerations for nitrosamine risk…
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Effects of polyvinylpyrrolidone and poly (ethylene glycol) on preparation of ibuprofen…
In this study, we investigated the effects of polymers on the pharmaceutical cocrystal formation process. Ibuprofen (IBU) was selected as the active pharmaceutical ingredient (API), nicotinamide (NIC) and saccharin (SAC) as the cocrystal coformer (CCF), ethanol/water as the solvent,…
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The future of novel excipients – by Croda Pharma
The importance of excipients
Formulation development has been emphasized greatly in recent years, whether that be for targeting delivery of the drug, aesthetics of the final formulation, or shelf life of the final drug product. Some excipients play a simple role in drug formulations while others…
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Enhancing Intradermal Delivery of Lidocaine by Dissolving Microneedles: Comparison between…
Lidocaine hydrochloride (LiH), an amide-type local anesthetic agent, is commonly used in dermatological procedures. LiH is categorized as a BCS (biopharmaceutics classification system) class III group, which has high solubility and poor permeability. It should be noted that, in this context, LiH is…
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Transform Your Brick-Dust API into an Effective oral Drug Candidate with Apinovex Polymers
Lubrizol Apinovex™ polymers can be easily incorporated into your drug project via spray drying or other solvent-based processes. This novel excipient has a broad API and solvent compatibility to produce Amorphous Solid Dispersions (ASD) of your brick-dust API.
1. Unlock the Potential Of…
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Thermodynamic Mechanism of Physical Stability of Amorphous Pharmaceutical Formulations
Hygroscopicity is an important factor affecting the physical stability of amorphous solid dispersions (ASDs) during long-term storage. In this work, the effects of temperature, relative humidity (RH), and polymeric excipients on the phase behavior of amorphous irbesartan (IRB) and oxaprozin (OXA)…
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Apinovex Polymers Enable Solubility With Ease
Apinovex™ polymers can be easily incorporated into your drug project via spray drying or other solvent-based processes. This novel excipient has a broad API and solvent compatibility to produce Amorphous Solid Dispersions (ASD) of your brick-dust API.
Solubility-enhancing polymers for oral…
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Preparation and in vitro evaluation of hot-melt extruded pectin-based pellets containing ketoprofen…
This work developed high drug-load pellets for colon targeting in minimal steps by coupling hot-melt extrusion (HME) with a die-surface cutting pelletizer, offering a potential continuous pellet manufacturing process. Ketoprofen (KTP) was selected as a model drug for this study due to its thermal…
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Temperature Cycling-Induced Formation of Crystalline Coatings
The surface of particles is the hotspot of interaction with their environment and is therefore a major target for particle engineering. Particles with tailored coatings are greatly desired for a range of different applications. Amorphous coatings applied via film coating or microencapsulation have…
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Oral Delivery of Niclosamide as an Amorphous Solid Dispersion That Generates Amorphous Nanoparticles…
Niclosamide is an FDA-approved anthelmintic that is being studied in clinical trials as a chemotherapeutic and broad-spectrum antiviral. Additionally, several other applications are currently in the preclinical stage. Unfortunately, niclosamide is a poorly water soluble molecule, with reduced oral…
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