ApoE-2 Brain-Targeted Gene Therapy Through Transferrin and Penetratin Tagged Liposomal Nanoparticles
AbstractPurposeApolipoprotein E2 (ApoE2) gene therapy is a potential disease-modifying therapy for Alzheimer ’s disease (AD). We investigated the potential of plasmid encoding ApoE2 loaded brain-targeted functionalized-liposomes for treatment of AD. This was achievedvia systemic administration of liposomes entrapping therapeutic gene targeting the brain of mice.MethodsTargeting and transfection efficiency of designed liposomes were determined in bEnd.3, primary glial and primary neuronal cells. The ability of liposomal formulations to translocate acrossin vitro blood-brain barrier (BBB) and, thereafter, transfect pri...
Source: Pharmaceutical Research - September 16, 2019 Category: Drugs & Pharmacology Source Type: research

Mucins are Involved in the Intestinal Permeation of Lipophilic Drugs in the Proximal Region of Rat Small Intestine
ConclusionsMucus limits the intestinal permeation of lipophilic drugs in the rat proximal small intestine, in which Muc5ac may be involved. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - September 16, 2019 Category: Drugs & Pharmacology Source Type: research

Glycine-Poly-L-Lactic Acid Copolymeric Nanoparticles for the Efficient Delivery of Bortezomib
ConclusionsBTZ loaded Gly4-PLA NPs apoptotic index was found to be much higher than BTZ but lesser than BTZ loaded FA-Gly4-PLA against breast cancer cell lines (MDA-MB-231). ROS intracellular assessment assay indicated that BTZ and BTZ loaded FA-Gly4-PLA NPs exhibited higher ROS production. Conclusively, the BTZ loaded FA-Gly4-PLA NPs were able to encapsulate more BTZ than BTZ loaded Gly4-PLA NPs and were found to be more effective as per asin vitro anti-cancer effect is concerned. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - September 13, 2019 Category: Drugs & Pharmacology Source Type: research

Gel Formation Induced Slow Dissolution of Amorphous Indomethacin
ConclusionsThe present study recommends that gel formation should be included in the investigation of amorphous materials in order to find ways for resolving defects of amorphous materials while keeping their advantages in pharmaceutics. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - September 12, 2019 Category: Drugs & Pharmacology Source Type: research

Metabolome Analysis Reveals Dermal Histamine Accumulation in Murine Dermatitis Provoked by Genetic Deletion of P-Glycoprotein and Breast Cancer Resistance Protein
ConclusionsThese results suggest possible association of these efflux transporters with dermal inflammatory mediators, and such association could be observed in the dermatitis skin. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - September 11, 2019 Category: Drugs & Pharmacology Source Type: research

Benefits of Fractal Approaches in Solid Dosage Form Development
AbstractPharmaceutical formulations are complex systems consisting of active pharmaceutical ingredient(s) and a number of excipients selected to provide the intended performance of the product. The understanding of materials ’ properties and technological processes is a requirement for building quality into pharmaceutical products. Such understanding is gained mostly from empirical correlations of material and process factors with quality attributes of the final product. However, it seems also important to gain knowle dge based on mechanistic considerations. Promising is here to study morphological and/or topological...
Source: Pharmaceutical Research - September 6, 2019 Category: Drugs & Pharmacology Source Type: research

Methotrexate Reduces the Clearance of Adalimumab by Increasing the Concentration of Neonatal Fc Receptor in Tissues
ConclusionsFcRn may play a vital role in the interaction between adalimumab and MTX. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - September 6, 2019 Category: Drugs & Pharmacology Source Type: research

Food, Acid Supplementation and Drug Absorption – a Complicated Gastric Mix: a Randomized Control Trial
ConclusionThe ability of food to elevate and maintain gastric pH levels in the presence of acid supplementation was made evident throughout the study. A 4500  mg dose of BHCl was required to reacidify gastric pH after the administration of food. This study details the difficulty faced by clinicians in dosing a poorly soluble, weakly basic drug to patients receiving acid reducing agents where administration with food is recommended to avoid gastric side effects.Trial Registration:https://clinicaltrials.gov/ct2/show/NCT02758015 (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - September 4, 2019 Category: Drugs & Pharmacology Source Type: research

Multicomponent Conjugates of Anticancer Drugs and Monoclonal Antibody with PAMAM Dendrimers to Increase Efficacy of HER-2 Positive Breast Cancer Therapy
ConclusionsOur results confirm the high selectivity of PAMAM-doc-trastuzumab and PAMAM-ptx-trastuzumab conjugates for HER-2-positive cells, and demonstrate the utility of trastuzumab as a targeting agent. Therefore, the analysed conjugates present an promising approach for the improvement of efficacy of targeted delivery of anticancer drugs such as docetaxel or paclitaxel. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - September 3, 2019 Category: Drugs & Pharmacology Source Type: research

Quality-by-Design Concepts to Improve Nanotechnology-Based Drug Development
In conclusion, QbD and the identification and specification of CQAs at its core are critical to the design, development and growth of nanomaterials in pharmaceuticals. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - September 3, 2019 Category: Drugs & Pharmacology Source Type: research

Analytical Platform for Monitoring Aggregation of Monoclonal Antibody Therapeutics
ConclusionsBased on the observations from the experiments, an analytical platform has been proposed covering the whole size spectrum that would be of utility to those engaged in formulation development as well as other aspects related to stability of biotherapeutic products. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - August 28, 2019 Category: Drugs & Pharmacology Source Type: research

Assessing the Utility of In Vitro Screening Tools for Predicting Bio-Performance of Oral Peptide Delivery
ConclusionThis study assessed the utility ofin vitro screening tools for selecting peptides and permeation excipients early in drug product development.Graphical Abstract Graphical Abstract and Figure 1 contains small text.Graphical Abstract text is made larger. The Figure 1 text cannot be made larger. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - August 26, 2019 Category: Drugs & Pharmacology Source Type: research

Understanding the Tabletability Differences between Indomethacin Polymorphs Using Powder Brillouin Light Scattering
ConclusionOur experimental, mechanical data is consistent with the predicted interaction topologies and these two inputs combined permit a comprehensive, molecular understanding of polymorph-specific tabletability. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - August 19, 2019 Category: Drugs & Pharmacology Source Type: research

Nano-Co-Delivery of Berberine and Anticancer Drug Using PLGA Nanoparticles: Exploration of Better Anticancer Activity and In Vivo Kinetics
This study was aimed to co-deliver berberine (natural origin) and doxorubicin (synthetic origin) utilizing conjugation/encapsulation strategy through poly (lactic-co-glycolic acid) (PLGA) nanoparticles.MethodsDoxorubicin was efficiently conjugated to PLGA via  carbodiimide chemistry and the PLGA-doxorubicin conjugate (PDC) was used for encapsulation of berberine (PDBNP).ResultsSignificant anti-proliferative against MDA-MB-231 and T47D breast cancer cell lines were observed with IC50 of 1.94  ± 0.22 and 1.02 ± 0.36 μM, which was significantly better than both the bio-actives (p 
Source: Pharmaceutical Research - August 16, 2019 Category: Drugs & Pharmacology Source Type: research

Medications in Space: In Search of a Pharmacologist ’s Guide to the Galaxy
AbstractMedications have been used during space missions for more than half a century, yet our understanding of the effects of spaceflight on drug pharmacokinetics and pharmacodynamics is poor. The space environment induces time-dependent alterations in human physiology that include fluid shifts, cardiovascular deconditioning, bone and muscle density loss, and impaired immunity. This review presents the current knowledge on the physiological effects of spaceflight that can translate into altered drug disposition and activity and eventually to inadequate treatment. It describes findings from studies in astronauts along with...
Source: Pharmaceutical Research - August 14, 2019 Category: Drugs & Pharmacology Source Type: research

Antibacterial Silver-Conjugated Magnetic Nanoparticles: Design, Synthesis and Bactericidal Effect
ConclusionsThe combination of magnetic properties together with bactericidal effects is suitable for the disinfection of medical instruments, water purification, food packaging, etc. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - August 14, 2019 Category: Drugs & Pharmacology Source Type: research

Anti-GPC3 Antibody Tagged Cationic Switchable Lipid-Based Nanoparticles for the Co-Delivery of Anti-miRNA27a And Sorafenib in Liver Cancers
ConclusionThe CSL-based G-S27LN efficiently co-delivered anti-microRNA27a and SRF and therefore represents a promising therapy to treat liver cancer. This study also brings forth a platform strategy for the effective treatment of number of other advanced cancers. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - August 8, 2019 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetic and Pharmacodynamic Modeling and Simulation Analysis of CTB-001, a Recently Developed Generic of Bivalirudin
ConclusionsThe modeling and simulation analysis well-characterized the PK and PD of CTB-001 in healthy Koreans, which will be valuable for identifying optimal dosing regimens of CBT-001. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - August 8, 2019 Category: Drugs & Pharmacology Source Type: research

Thermal Sensitive Liposomes Improve Delivery of Boronated Agents for Boron Neutron Capture Therapy
ConclusionThis is the first study to show the delivery of boronated compounds using TSLs for BNCT, and these results will provide the basis of future clinical trials using TSLs for BNCT. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - August 7, 2019 Category: Drugs & Pharmacology Source Type: research

Octreotide Nanoparticles Showed Affinity for In Vivo MIA Paca-2 Inducted Pancreas Ductal Adenocarcinoma Mimicking Pancreatic Polypeptide-Secreting Tumor of the Distal Pancreas (PPoma)
ConclusionThe results support the use of this nanosystem (99mTc-PLA/PVA octreotide nanoparticles) as imaging agent for PPoma.Graphical AbstractPolypeptide-Secreting Tumor of the Distal Pancreas (PPoma) Radiolabeled Nanoparticles for Imaging (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - August 5, 2019 Category: Drugs & Pharmacology Source Type: research

Identification of Factors of Importance for Spray Drying of Small Interfering RNA-Loaded Lipidoid-Polymer Hybrid Nanoparticles for Inhalation
ConclusionThe optimal solid dosage forms represent robust formulations suitable for higher scale-up manufacturing. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - August 2, 2019 Category: Drugs & Pharmacology Source Type: research

Sugar Modification Enhances Cytotoxic Activity of PAMAM-Doxorubicin Conjugate in Glucose-Deprived MCF-7 Cells – Possible Role of GLUT1 Transporter
ConclusionOur findings revealed that the glucose moiety plays a crucial role in the recognition of cells with high expression of GLUT receptors. By selectively blocking GLUT1 transporter we showed its importance for the cytotoxic activity of PAMAM-dox-glc conjugate. These results suggest that PAMAM-glucose formulations may constitute an efficient platform for the specific delivery of anticancer drugs to tumor cells overexpressing transporters of GLUT family. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 31, 2019 Category: Drugs & Pharmacology Source Type: research

Changes of Blood-Brain Barrier and Brain Parenchymal Protein Expression Levels of Mice under Different Insulin-Resistance Conditions Induced by High-Fat Diet
ConclusionOur results suggest that changes in the status of insulin resistance influence expression of BBB transporters, which in turn may alter the expression of cognitive function-related proteins. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 31, 2019 Category: Drugs & Pharmacology Source Type: research

Minimum Interfacial Bonding Strength for Bilayer Tablets Determined Using a Survival Test
ConclusionsA minimum IBS of 0.26  MPa is recommended as a tentative criterion for bilayer tablets of most materials to avoid quality issues arising from inadequate IBS. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 29, 2019 Category: Drugs & Pharmacology Source Type: research

Preparation of Ondansetron Hydrochloride-Loaded Nanostructured Lipid Carriers Using Solvent Injection Method for Enhancement of Pharmacokinetic Properties
ConclusionsThe ODS-loaded NLCs appear potential for prolongation of drug action and reduction in dosing frequency. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 26, 2019 Category: Drugs & Pharmacology Source Type: research

Repurposing Approved Drugs as Inhibitors of K v 7.1 and Na v 1.8 to Treat Pitt Hopkins Syndrome
ConclusionsThis work could lead to the potential repurposing of nicardipine or other dihydropyridine calcium channel antagonists as potential treatments for PTHS acting via Nav1.8, as there are currently no approved treatments for this rare disorder. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 22, 2019 Category: Drugs & Pharmacology Source Type: research

Development and Characterization of a Dry Powder Formulation for Anti-Tuberculosis Drug Spectinamide 1599
ConclusionsThe corresponding systemic drug exposure data indicates dose-dependent exposurein vivo in mice after dry powder intrapulmonary aerosol delivery in the dose range 15.4  - 32.8 mg/kg. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 18, 2019 Category: Drugs & Pharmacology Source Type: research

Item Response Model Adaptation for Analyzing Data from Different Versions of Parkinson ’s Disease Rating Scales
ConclusionAn IRM able to handle two variants of clinical PD endpoints was developed; it can improve the utilization of data from diverse sources and diverse disease populations. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 17, 2019 Category: Drugs & Pharmacology Source Type: research

Challenging the CNS Targeting Potential of Systemically Administered Nanoemulsion Delivery Systems: a Case Study with Rapamycin-Containing Fish Oil Nanoemulsions in Mice
ConclusionsOur findings confirm that BBB penetration, which primarily depends on intrinsic drug-related properties, may not be significantly improved following encapsulation of drugs in nanoemulsions.Graphical AbstractThe CNS targeting potential of systemically administered nanoemulsions was investigated by formulating various rapamycin containing fish oil nanoemulsions associated with different formulation characteristics such as the circulation half-life and particle size distribution. The targeting efficiency (TE) defined as the ratio of the brain exposures to the accompanying systemic exposures of rapamycin was estimat...
Source: Pharmaceutical Research - July 11, 2019 Category: Drugs & Pharmacology Source Type: research

Targeting KRAS Mutant Lung Cancer Cells with siRNA-Loaded Bovine Serum Albumin Nanoparticles
ConclusionsBSA nanoparticles loaded with mutant specific siRNA are a promising therapeutic approach for KRAS-mutant cancers. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 9, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Impact of Buffer, Protein Concentration and Sucrose Addition on the Aggregation and Particle Formation during Freezing and Thawing
The statement in the caption to Fig.  1 “Data taken from reference (38). ” (Kolhe P, Holding E, Lary A, Chico S, Singh SK. Large-scale freezing of biologics: understanding protein and solute concentration changes in a Cryovessel-part 2. Biopharm International. 2010;23(7):40 –9) is erroneous. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 8, 2019 Category: Drugs & Pharmacology Source Type: research

Increased Nose-to-Brain Delivery of Melatonin Mediated by Polycaprolactone Nanoparticles for the Treatment of Glioblastoma
ConclusionsNanoencapsulation of MLT was crucial for the selective antitumoral activity against U87MG.In vivo evaluation confirmed nose-to-brain delivery of MLT mediated by nanoparticles, highlighting the formulation as a suitable approach to improve glioblastoma therapy. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 1, 2019 Category: Drugs & Pharmacology Source Type: research

Utility of High Resolution NMR Methods to Probe the Impact of Chemical Modifications on Higher Order Structure of Monoclonal Antibodies in Relation to Antigen Binding
ConclusionThis case study provides an integrated approach of relating chemical modifications in mAb domains with possible changes in HOS. This can be potentially used to assess a possible loss of potency within the structure-function paradigm of proteins in an orthogonal manner. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - July 1, 2019 Category: Drugs & Pharmacology Source Type: research

Generation, Characterization, and Quantitative Bioanalysis of Drug/Anti-drug Antibody Immune Complexes to Facilitate Dedicated In Vivo Studies
ConclusionsThe developedin vitro IC model system has been properly characterized by biophysical and bioanalytical methods. The specificity of the developed methods enable discrimination between different oligomeric states of ICs and can be bench marking for futurein vivo studies with ICs. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - June 28, 2019 Category: Drugs & Pharmacology Source Type: research

An Effective Technology for the Development of Immediate Release Solid Dosage Forms Containing Low-Dose Drug: Fused Deposition Modeling 3D Printing
ConclusionsThe same rapid release profiles with conventional IR tablets can be reached by making only physical changes on 3D tablets without using any filling or disintegrating agents. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - June 27, 2019 Category: Drugs & Pharmacology Source Type: research

High Pressure Nebulization (PIPAC) Versus Injection for the Intraperitoneal Administration of mRNA Complexes
ConclusionThis study demonstrated that local nebulization is feasible to apply mRNA complexes in the peritoneal cavity during a PIPAC procedure. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - June 24, 2019 Category: Drugs & Pharmacology Source Type: research

Model-based analysis of treatment effects of paclitaxel microspheres in a microscopic peritoneal carcinomatosis model in mice
ConclusionsThe model predicts that the dose range of 7.5-15 mg/kg of PTXnano-GP-MS provides an optimal balance between efficacy and safety. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - June 24, 2019 Category: Drugs & Pharmacology Source Type: research

Recent Treatment Advances and the Role of Nanotechnology, Combination Products, and Immunotherapy in Changing the Therapeutic Landscape of Acute Myeloid Leukemia
AbstractAcute myeloid leukemia (AML) is the most common acute leukemia that is becoming more prevalent particularly in the older (65  years of age or older) population. For decades, “7 + 3” remission induction therapy with cytarabine and an anthracycline, followed by consolidation therapy, has been the standard of care treatment for AML. This stagnancy in AML treatment has resulted in less than ideal treatment outcomes f or AML patients, especially for elderly patients and those with unfavourable profiles. Over the past two years, six new therapeutic agents have received regulatory approval, ...
Source: Pharmaceutical Research - June 24, 2019 Category: Drugs & Pharmacology Source Type: research

Heat Enhanced Follicular Delivery of Isotretinoin to the Skin
ConclusionThese data indicate that the use of short durations of heat combined with chemical penetration enhancers offers a valuable strategy for improving the delivery of drugs such as isotretinoin to the skin via the hair follicles.Graphical AbstractSchematic illustration of the sodium thiosulphate heating system on a Franz diffusion cell and the subsequent impact of a short burst of heat on the delivery of isotretinoin into human skin. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - June 21, 2019 Category: Drugs & Pharmacology Source Type: research

Folate Conjugated Double Liposomes Bearing Prednisolone and Methotrexate for Targeting Rheumatoid Arthritis
ConclusionsThe folate conjugated double liposomes possess superior targeting efficiency than conjugated and unconjugated single liposomes. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - June 19, 2019 Category: Drugs & Pharmacology Source Type: research

Non-Propellant Foams of Green Nano-Silver and Sulfadiazine: Development and In Vivo Evaluation for Burn Wounds
AbstractPurposeA non-propellant based foam (NPF) system was developed incorporating the antibiotics, pectin capped green nano-silver and sulfadiazine (SD) for the topical treatment of burn wounds as a convenient alternative to the existing therapies.MethodsNPF were prepared using various surfactants and oils forming a nanoemulsion. Anti-microbial studies by resazurin microtitre assay,ex vivo diffusion,in vivo skin permeation and deposition studies, and acute irritation studies were carried out. NPF was applied onto secondary thermal wounds manifested on mice models followed by macroscopic and histological examinations.Resu...
Source: Pharmaceutical Research - June 19, 2019 Category: Drugs & Pharmacology Source Type: research

Development of β-elemene and Cisplatin Co-Loaded Liposomes for Effective Lung Cancer Therapy and Evaluation in Patient-Derived Tumor Xenografts
Conclusionβ-elemene and cisplatin co-loaded liposomes are a clinically promising candidate for effective lung cancer therapy. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - June 18, 2019 Category: Drugs & Pharmacology Source Type: research

Inhaler Spray Investigation Using High-Speed Phase-Contrast X-Ray and Schlieren Imaging
ConclusionsAs the foamy liquid-vapour mixture is forced out of the sump and into the orifice the liquid walls of the bubbles break into fragments which are forced out of the sump and tend to form a liquid-gas flow in the orifice channel. The period of high density plume observed by the schlieren technique corresponds to flash-boiling-driven liquid exiting the orifice channel. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - June 18, 2019 Category: Drugs & Pharmacology Source Type: research

Proton Oriented- “Smart Depot” for Responsive Release of Ca 2+ to Inhibit Peptide Acylation in PLGA Microspheres
ConclusionsWith the presence of the smart Ca2+ depot (Ca3(PO4)2) in the microspheres, a sustainable and long-term inhibition of peptide acylation was achieved. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - June 4, 2019 Category: Drugs & Pharmacology Source Type: research

MOF Capacitates Cyclodextrin to Mega-Load Mode for High-Efficient Delivery of Valsartan
ConclusionsThe new understanding of drug nanoclusters in CD-MOF will help to design more efficient drug delivery systems using CD-MOF carrier with nanocavities. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - June 3, 2019 Category: Drugs & Pharmacology Source Type: research

Natural Deep Eutectic Solvents as Agents for Improving Solubility, Stability and Delivery of Curcumin
ConclusionsSuspension of curcumin in NADES offers beneficial properties of this new liquid drug formulation starting from excreting from natural sources, through safe storage and ending on the final administration route. Therefore, there is a possibility of using a one-step process with this medium. The performed quantum chemistry computations clearly indicated the origin of the enhanced solubility of curcumin in NADES in the presence of intestinal fluids. Direct intermolecular contacts leading to hetero-molecular pairs with choline chloride and glycerol are responsible for elevating the bulk concentration of curcumin. Cho...
Source: Pharmaceutical Research - June 3, 2019 Category: Drugs & Pharmacology Source Type: research

Fibrin Gels Entrapment of a Poly-Cyclodextrin Nanocarrier as a Doxorubicin Delivery System in an Orthotopic Model of Neuroblastoma: Evaluation of In Vitro Activity and In Vivo Toxicity
ConclusionOur results suggest a possible increase of the therapeutic index of Dox when locally administered through FBGs loaded with oCD-NH2/Dox, opening the possibility of using these releasing systems for the treatment of neuroblastoma. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - June 3, 2019 Category: Drugs & Pharmacology Source Type: research

Uncommon Peptide Bond Cleavage of Glucagon from a Specific Vendor under near Neutral to Basic Conditions
ConclusionsThe degradation phenomenon described here could be used as an excellent example showing that products ordered from vendors meeting the rudimentary quality standards might contain impurities which could cause significant degradation. We suggest that a simple solution, i.e. additional tests of stability under real or accelerated conditions by manufacturers and inclusion of the “accelerated stability criteria” in the Certificate of Analysis (CoAs), especially for sensitive biological reagents prone to faster degradation, would be very helpful for avoiding losses for both vendors and users. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - June 3, 2019 Category: Drugs & Pharmacology Source Type: research

Drug Interactions in Space: a Cause for Concern?
ConclusionsMost potential DDIs likely to be encountered in space are unestablished even in terrestrial medicine and their assignment is based on class-effects. Yet, some drug combinations may be associated with clinically-relevant consequences. Future DDI rating should be adjusted to space-related outcomes. Until that happens, it would be advisable to avoid non-established drug combinations in space when possible. (Source: Pharmaceutical Research)
Source: Pharmaceutical Research - May 31, 2019 Category: Drugs & Pharmacology Source Type: research

Interlaboratory Variability in Human Hepatocyte Intrinsic Clearance Values and Trends with Physicochemical Properties
ConclusionsCaution should be taken when compilingin vitro CLint values from different laboratories as variations in experimental procedures (such as extent of shaking during incubation) may yield different predictions for the same compound. The majority of compounds with uniformin vitro values had predictions that were inaccurate, emphasizing the need for a better mechanistic understanding of IVIVE. The non-uniform predictions, often with low turnover compounds, reaffirmed the experimental challenges for drugs in this clearance range. Separating new chemical entities by lipophilicity, intrinsic clearance, and protein bindi...
Source: Pharmaceutical Research - May 31, 2019 Category: Drugs & Pharmacology Source Type: research