29. September 2018
Tobramycin (TOB) and clarithromycin (CLA) can potentially be used synergistically for the treatment of respiratory infections caused by Pseudomonas aeruginosa (P. aeruginosa) in cystic fibrosis (CF) patients. This study aimed to develop a novel combination proliposome formulation (TOB/CLA-CPROLips) containing both hydrophilic TOB and hydrophobic CLA via a core-carrier approach. The combination proliposomes were produced by spray drying a suspension comprising spray-driedmannitol (SD-MAN, 0.45...
14. June 2018
The brand new Glatt TwinPro® is absolutely revolutionary. It combines two previously single batch processes into one single process: High Shear Granulation and Fluidized Bed Drying. Critical aspects like product Transfer and wet sieving are eliminated, process time is enormously shortend. Glatt TwinPro® - Innovation by Experience. TwinPro® is the winner of the Achema 2018 Innovation Award - Category Pharmaceutical Technologies.
27. April 2018
This article reviews regulatory considerations for companies wishing to develop drugs for delivery via the respiratory tract (e.g., by oral inhalation or intranasally) using molecules previously approved for a different therapeutic indication and/or a different delivery route. Conceptually, such repurposing has many medical and business advantages, but turning promising ideas into real products requires overcoming a number of practical challenges. Obtaining regulatory approval to market a...
06. January 2018
It is unknown if inactive pharmaceutical ingredients influence the activity of antibiotics they are co-formulated with. Recently it was found that materials acting as carbon nutrient sources for bacteria can promote bacterial dispersion from a biofilm and/or reverse the persister state of a subpopulation of bacteria within the biofilms. Both can make bacteria more susceptible to antibiotics.
24. April 2017
Abstract Personalized medicine is an important treatment approach for diseases like cancer with high intrasubject variability. In this framework, printing is one of the most promising methods since it permits dose and geometry adjustment of the final product. With this study, a combination product consisting of anticancer (paclitaxel) and antiviral (cidofovir) drugs was manufactured by inkjet printing onto adhesive film for local treatment of cervical cancers as a result of HPV infection....
22. April 2017
Abstract Mini-tablets have potential applications as a flexible drug delivery tool in addition to their generally perceived use as multi-particulates. That is, mini-tablets could provide flexibility in dose finding studies and/or allow for combination therapies in the clinic. Moreover, mini-tablets with well controlled quality attributes could be a prudent choice for administering solid dosage forms as a single unit or composite of multiple mini-tablets in patient populations with swallowing...
07. February 2017
Abstract Enteric-coated fixed-dose combinations of ezetimibe and lovastatin were prepared by fluid bed coating aiming to avoid the acidic conversion of lovastatin to its hydroxyacid derivative. In a two-step process, sucrose beads were layered with a glass solution of ezetimibe, lovastatin and Soluplus®, top-coated with an enteric layer. The impact of different bead size, enteric polymers (Eudragit L100® and Eudragit L100-55®) and coating time was investigated. Samples were evaluated by...
24. November 2016
Abstract The use of fixed dose combination (FDC) drug therapies has been world-widely accepted for long years due to providing better disease treatment with enhanced therapeutic efficacy and safety as well as improved patient compliance and adherence, and reduced cost to patients than single drug therapies. From many different perspectives, the development of FDC products is likely a promising approach to achieving clinical benefits and business advantages in many classes of drugs. The...
17. January 2016
This study aimed to design a fixed-dose combination dosage form which provides a sustained release profile for both the freely water-soluble metformin HCl and the poorly soluble gliclazide, two antidiabetic compounds used to treat diabetes mellitus. More
07. November 2015
IPEC Presentation by Meera Raghuram Manager, Global Regulatory Affairs and Strategies – Lubrizol LifeSciences Chair – Regulatory Affairs Committee, IPEC-Americas Link