Drug-device combination product, which comprises at least a drug and a medical device, has been proved to effectively reduce the risk of complications accompanied with conventional medical devices implantation, and has a great clinical success especially in implantable therapeutics. Herein, we firstly elaborated the definitions and requirements of drug-device combination product in different countries, then summarized the market application and research development of typical drug-device combination products. Technical problems and the trend of future development had also been analyzed.
Drug Delivery Systems/instrumentation* ; Equipment Design ; Prostheses and Implants

To evaluate the efficacy and safety of drug-eluding beads transarterial chemoembolization (DEB-TACE) in treatment of unrecectable hepatocellular carcinoma (HCC).The clinical data of 42 consecutive HCC patients undergoing TACE were retrospectively analyzed, including 20 cases received conventional TACE (cTACE group) and 22 cases received TACE with epirubicine-loaded microspheres (CalliSpheres) (DEB-TACE group). MRI scans were performed 1 week before and 1, 3 and 6 months after initial therapy. The response to treatment, disease recurrence, complications and adverse effects were documented and compared between two groups.There were no significant differences in 1-month, 3-month and 6-month objective response rate (CR+PR) and disease control rate (CR+PR+SD), disease recurrence, complications and adverse effects of interventional therapy between cTACE group and DEB-TACE group. Additionally, there were no significant differences about locoregional biliary injuries, intrahepatic biloma, and newly detected intra- or extrahepatic HCC on MRI between cTACE group and DEB-TACE group.There were no statistically significant differences between cTACE group and DEB-TACE group with regard to the short-term response, disease recurrence, complications and side effects. Hepatic-locoregional complications may be more frequent in DEB-TACE group than those in cTACE group.
Carcinoma, Hepatocellular ; diagnostic imaging ; therapy ; Chemoembolization, Therapeutic ; adverse effects ; instrumentation ; methods ; Comparative Effectiveness Research ; Drug Delivery Systems ; instrumentation ; methods ; Epirubicin ; administration & dosage ; therapeutic use ; Humans ; Liver Neoplasms ; Magnetic Resonance Imaging ; Microspheres ; Neoplasm Recurrence, Local ; Retrospective Studies ; Treatment Outcome

New enrofloxacin microspheres were formulated, and their physical properties, lung-targeting ability, and tissue distribution in rats were examined. The microspheres had a regular and round shape. The mean diameter was 10.06 microm, and the diameter of 89.93% of all microspheres ranged from 7.0 microm to 30.0 microm. Tissue distribution of the microspheres was evaluated along with a conventional enrofloxacin preparation after a single intravenous injection (7.5 mg of enrofloxacin/kg bw). The results showed that the elimination half-life (t(1/2beta)) of enrofloxacin from lung was prolonged from 7.94 h for the conventional enrofloxacin to 13.28 h for the microspheres. Area under the lung concentration versus time curve from 0 h to infinity (AUC(0-infinity)) was increased from 11.66 h.microg/g to 508.00 h.microg/g. The peak concentration (Cmax) in lung was increased from 5.95 microg/g to 93.36 microg/g. Three lung-targeting parameters were further assessed and showed that the microspheres had remarkable lung-targeting capabilities.
Animals ; Anti-Bacterial Agents/*adverse effects ; Drug Delivery Systems/instrumentation/*methods ; Female ; Fluoroquinolones/*adverse effects ; Half-Life ; Humans ; Injections, Intravenous ; Lung/*drug effects ; Male ; *Microspheres ; Rats ; Rats, Sprague-Dawley ; Tissue Distribution

The present study was designed to develop and evaluate glycyrrhetinic acid-graft-hyaluronic acid (HGA) conjugate for intravenous paclitaxel (PTX) delivery. Lyophilized PTX-loaded self-assembled HGA nanoparticles (PTX/HGAs) were prepared and characterized by dynamic light scattering measurements. Hemolysis test, intravenous irritation assessment, and in vitro and in vivo pharmacodynamic studies were carried out. B16F10 and HepG2 cells were used in the cell apoptosis analysis. The mouse MDA-MB-231 xenograft model was used for the evaluation of in vivo anticancer activity of the drugs, by the analysis of tumor growth and side effects on other tissues. PTX/HGAs showed high stability and good biocompability. Compared with PTX plus GA plus HA solution, PTX/HGAs displayed obvious superiority in inducing the apoptosis of the cancer cells. Following systemic administration, PTX/HGAs efficiently suppressed tumor growth, with mean tumor inhibition ratio (TIR) being 65.08%, which was significantly higher than that of PTX plus GA plus HA treatment. In conclusion, PTX/HGAs demonstrated inhibitory effects tumor growth without unwanted side effects, suggesting that HGA conjugates hold a great potential as a delivery carrier for cancer chemotherapeutics to improve therapeutic efficacy and minimize adverse effects.
Animals ; Antineoplastic Agents ; administration & dosage ; adverse effects ; chemistry ; Apoptosis ; drug effects ; Drug Carriers ; chemistry ; Drug Delivery Systems ; instrumentation ; methods ; Drug Synergism ; Female ; Glycyrrhetinic Acid ; chemistry ; Hep G2 Cells ; Humans ; Hyaluronic Acid ; chemistry ; Male ; Mice ; Paclitaxel ; administration & dosage ; adverse effects ; chemistry

OBJECTIVETo compare the dissolution characteristics of colloidal silica and porous silica as the solid dispersion carrier, with baicalin as the model drug.

METHODThe baicalin solid dispersion was prepared by the solvent method, with colloidal silica and porous silica as the carriers. In the in vitro dissolution experiment, the solid dispersion was identified by scanning electron microscopy, differential scanning and X-ray diffraction.

RESULTThe solid dispersion carriers prepared with both colloidal silica and porous silica could achieve the purpose of rapid release. Along with the increase in the proportion of the carriers, the dissolution rate is accelerated to more than 80% within 60 min. Baicalin existed in the solid dispersion carriers in the non-crystalline form.

CONCLUSIONThe release behaviors of the baicalin solid dispersion prepared with two types of carrier were different. Among the two solid dispersion carriers, porous silica dissolved slowly than colloidal silica within 60 min, and they showed similar dissolutions after 60 min.

Calorimetry, Differential Scanning ; Colloids ; chemistry ; Drug Carriers ; chemistry ; Drug Delivery Systems ; instrumentation ; Flavonoids ; chemistry ; pharmacology ; Porosity ; Silicon Dioxide ; chemistry ; Solubility

The paeonol proniosomes ointment and ordinary ointment were administered to rats. Physiological saline served as perfused solution. The perfusion rate was 5 mL x L(-1) and the microdialysis samples were collected every 20 min intervals. The paeonol concentration in perfused solution was determined by HPLC. Investigation of the pharmacokinetics of paeonol proniosomes ointment and ordinary ointment by the skin-blood synchronous microdialysis coupled with HPLC is reported in this study. The results show that the recovery was (54.80 +/- 1.50)% in vitro and (54.58 +/- 4.61)% in vivo. The results showed that paeonol proniosomes ointment significantly raised the drug concentrations in skin more than the paeonol ordinary ointment. The paeono proniosomes ointment has less drugs into the blood as the ordinary ointments in blood, but its blood drug concentrations were steadier. The paeonol proniosomes ointment may be developed into a new preparation.
Acetophenones ; administration & dosage ; blood ; chemistry ; pharmacokinetics ; Animals ; Drug Delivery Systems ; instrumentation ; methods ; Drugs, Chinese Herbal ; administration & dosage ; chemistry ; pharmacokinetics ; Male ; Microdialysis ; Ointments ; administration & dosage ; chemistry ; pharmacokinetics ; Paeonia ; chemistry ; Rats ; Rats, Wistar ; Skin ; metabolism

The study aims to investigate the effect of the ratio of long axis to short axis (RLS) of upright polypropylene infusion bag on discharging process and to search the best RLS. Aiming at five different RLS (1. 5 : 1, 2 : 1, 3 : 1, 4 : 1 and 5 : 1, respectively) with the volume of 100 mL, 250 mL and 500 mL, respectively, based on finite element method, analyzing the variation of stress distribution, emptying rate, drugging space and steadiness coefficient, etc. For the bags of the same volume, emptying rate increased with increasing of RLS, but the steadiness coefficient decreased with increasing of RLS. The specific increasing amplitude of emptying rate and decreasing range of steadiness coefficient were as follows: 20% and 49% for 100 mL infusion bag, 9% and 51% for 250 mL infusion bag, and 11% and 46% for 500 mL infusion bag, respectibvely, when RLS increased from 1. 5 : 1 to 5 : 1. Comparatively speaking, the increasing amplitude of the emptying rate is remarkably less than the decreasing range of the steadiness coefficient. By comprehensive consideration of both emptying rate and steadiness coefficient, lower RLS is recommended for upright polypropylene infusion bag.
Drug Delivery Systems ; instrumentation ; Finite Element Analysis ; Polypropylenes

Relatively uniform-sized nanoparticles made of poly (lactic-co-glycolic acid) (PLGA) were prepared by premix membrane emulsification method. After the drug loading property was completed, the dynamic tissue distribution of nanoparticles was recorded. With the average particle size and span as indexes, membrane pore size, number of passing membrane times, membrane pressure, volume ratio of oil-water phase and the concentration of poly(vinyl alcohol) (PVA) in external water phase were investigated by single factor test, the optimum preparation technology of blank PLGA nanlparticles was as following: pore size of SPG membrane was 1 μm, membrane pressure was 1. 15 MPa, the number of passing membrane time was 3, the mass fraction of PVA of 2%, volume ratio of oil-water phase of 1 : 5. Prepared nanoparticles were round with smooth surface, the mean diameter was 332.6 nm, span was 0.010, the confocal laser scanning microscope (CLSM) concluded that fluorescent substance is uniform composizion in PLGA nanoparticle, and the in vivo imaging technology in mice include that the nanoparticles show good liver and spleen targeting property.
Animals ; Drug Carriers ; chemistry ; Drug Delivery Systems ; instrumentation ; Emulsions ; chemistry ; Fluorescent Dyes ; chemistry ; Lactic Acid ; chemistry ; Mice ; Mice, Nude ; Nanoparticles ; chemistry ; Particle Size ; Polyglycolic Acid ; chemistry

Paracetamol was used as a model drug in this study to investigate the synergetic effects of lipid coating and beta-cyclodextrin (beta-CD) inclusion for masking the bitter taste of poorly soluble drugs. To control the concentration as low as possible of the free drug which produced a bitter taste, a kinetic model was established to calculate the drug distribution theoretically among the free drug in medium, lipid coated particles and molecular inclusion on the basis of the preparation and characterization of the lipid microspheres, so as to select the proper amount of beta-CD. Finally, the synergetic drug delivery systems were prepared and characterized by 1H nuclear magnetic resonance (1H NMR), molecular simulation and the electronic tongue. As a result, the drug release rate constant (k) of the lipid microspheres coated with octadecanol was determined as 0.001 270 s(-1). Then, the synergetic drug delivery systems were prepared with the ratio of 6.74 : 1 (w/w) for beta-CD and paracetamol. The chemical shift values for the fingerprint peaks of paracetamol all increased and hydrogen bonds were formed between the oxygen on the phenolic hydroxyl group, the nitrogen on the imino in paracetamol and the hydrogens on the hydroxyl groups in beta-CD. The results tested by the electronic tongue indicated that the paracetamol, lipid microspheres, beta-CD inclusion and their mixture showed different taste characteristics, with the bitterness order of the synergetic drug delivery systems approximately lipid microspheres < beta-CD inclusion < paracetamol, which confirmed the synergetic taste masking effects of lipid coating and beta-CD molecular inclusion. In summary, the synergetic taste masking was jointly achieved through the retard of the drug release by the lipid coating and the inclusion of the free paracetamol by beta-CD through hydrogen bonds.
Acetaminophen ; administration & dosage ; chemistry ; Administration, Oral ; Drug Delivery Systems ; Electrical Equipment and Supplies ; Electrochemical Techniques ; instrumentation ; methods ; Hydrogen Bonding ; Kinetics ; Lipids ; chemistry ; Microspheres ; Solubility ; Taste ; drug effects ; beta-Cyclodextrins ; chemistry

Responsive drug delivery system can release drug at specific time and sites, and effectively overcome the drug resistance of organisms. With such advantages as drug protection, local targeting, inhibition of enzymatic activity, memory and expression, it has good prospect of application. So far, many chemical preparations have been launched in the market. This article mainly summarizes the advance in studies on establishment methods of responsive drug delivery system, while proposing research ideas for the traditional Chinese medicine component-based responsive drug delivery system according to the multi-component, multi-link and multi-target characteristics, in the expectation of providing reference and thought for the development of the drug delivery system.
Animals ; Drug Delivery Systems ; instrumentation ; methods ; trends ; Drugs, Chinese Herbal ; administration & dosage ; chemistry ; Humans