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PubMed2004

Simultaneous conductivity and viscosity measurements as a technique to track emulsion inversion by the phase-inversion-temperature method.

Two kinds of transitions can occur when an emulsified water-oil-ethoxylated nonionic surfactant system is cooled under constant stirring. At a water-oil ratio close to unity, a transitional inversion takes place from a water-in-oil (W/O) to an oil-in-water (O/W) morphology according to the so-called phase-inversion-temperature method. At a high water content, a multiple w/O/W emulsion changes to a simple O/W emulsion. The continuous monitoring of both the emulsion conductivity and viscosity allows the identification of several phenomena that take place during the temperature decrease. In all cases, a viscosity maximum is found on each side of the three-phase behavior temperature interval and correlates with the attainment of extremely fine emulsions, where the best compromise between a low-tension and a not-too-unstable emulsion is reached. The studied system contains Polysorbate 85, a light alkane cut oil, and a sodium chloride brine. All transitions are interpreted in the framework of the formulation-composition bidimensional map.

Journal Article↗
PubMed2006

Nonionic block copolymer antifoams.

Aqueous dispersions of alkoxylated alcohol block copolymer (BCP) drops are investigated as antifoams. A model aqueous nonionic surfactant solution of Polysorbate 20 and an industrial white water suspension are used as foaming systems. Visual evidence obtained using a two-bubble technique involving a CCD camera coupled with high magnification lenses clearly revealed the role of BCP droplets in the bubble coalescence process. The enhancement of bubble coalescence decreased as the temperature increased from 25 to 60 degrees C, which is due to the corresponding decrease in the rigidity associated with the weak interfacial structure and reduced viscosity of the BCP drops. The antifoaming efficiency measured in the macroscopic recirculation foam column increased with temperature from about 13 to 26 degrees C (attaining a maximum) and decreased as temperature increased further. Oscillatory thermo-rheometric measurements showed a sudden increase in the storage modulus (G') by several orders of magnitude, indicating gel formation initiated at about 13 degrees C and having a maximum at around 26 degrees C for an aqueous solution of the BCP above a critical concentration of around 20 wt %. Results obtained using small-angle X-ray scattering, micro-differential scanning calorimetry, and proton nuclear magnetic resonance confirmed the existence of ordered gel-like structures. Furthermore, macroscopic tests using a sparged air foam column showed a significant increase in antifoaming efficiency when highly hydrophobic particles are embedded in the BCP drops dispersed in water.

Journal Article↗
PubMed2000

Preparation of biodegradable insulin nanocapsules from biocompatible microemulsions.

PURPOSE: To prepare poly(ethyl 2-cyanoacrylate) nanocapsules containing insulin by interfacial polymerization of spontaneously forming, biocompatible microemulsions. METHODS: A pseudo-ternary phase diagram of a mixture of medium chain glycerides (caprylic/capric triglycerides and mono-/diglycerides), a mixture of surfactants (polysorbate 80 and sorbitan mono-oleate) and water was constructed. Polarizing light microscopy was used to identify combinations forming microemulsions. Microemulsions were characterized by conductivity and viscosity to select systems suitable for the preparation of poly(ethyl 2-cyanoacrylate) nanocapsules by interfacial polymerization. Nanocapsules were prepared by addition of 100 mg of ethyl 2-cyanoacrylate to a stirred water-in-oil microemulsion containing 1 g of water, 7.6 g of oil, and 1.4 g of surfactant. The nanocapsules formed were characterized by photon correlation spectroscopy, freeze fracture transmission and scanning electron microscopy. Insulin nanocapsules were prepared by using an aqueous solution of insulin (100 units/ml) as the dispersed phase of the microemulsion. The entrapment and the release of insulin from the nanocapsules were determined. RESULTS: Three regions were identified in the pseudo-ternary phase diagram; a microemulsion region, a region in which liquid crystalline structures were present and a coarse emulsion region. All systems in the microemulsion region were water-in-oil dispersions. Poly(ethyl 2-cyanoacrylate) nanocapsules having a mean particle size of 150.9 nm were formed upon interfacial polymerization of the microemulsion. Nanocapsules were found to have a central cavity surrounded by a polymer wall. In excess of 80% of the insulin present in the microemulsion was encapsulated upon interfacial polymerization. CONCLUSIONS: Interfacial polymerization of spontaneously forming water-in-oil microemulsions represents a convenient method for the preparation of poly(alkylcyanoacrylate) nanocapsules suitable for the entrapment of bioactive peptides.

Absorbable Implants↗
PubMed1998

Development of novel chitosan derivatives as micellar carriers of taxol.

PURPOSE: To develop an intravenous injectable carrier composed of chitosan derivatives for taxol. METHODS: A chitosan with lauryl groups attached to amino groups to provide the hydrophobic moieties and, carboxymethyl groups attached to hydroxy groups to provide the hydrophilic moieties (N-lauryl-carboxymethyl-chitosan = LCC), was newly synthesized. The solubility of taxol in LCC micelles in aqueous solution was examined. The hemolysis test of LCC and the growth inhibition experiment of taxol-loading micelle using KB cells were also performed as in vitro assay. RESULTS: It was found that LCC solubilized taxol by forming micelles with particle sizes less than 100nm. This particle size was considered effective for passive targeting for tumors. The concentration of taxol in the micellar solution was very high, with a maximum of 2.37mg/mL. This maximum was 1000 times above that in a saturated solution of taxol at pH 7.4. Hemolysis testing as an in vitro assay indicated that LCC was safer than Polysorbate 80 (TO-10M) as intravenous surfactant in terms of induction of membrane damage. As judged by cytostatic activity against KB cells, taxol retained activity even when included in LCC micelles. LCC-entrapped taxol was more effective in cytostatic activity than free taxol in low concentrations. CONCLUSIONS: The results of solubilization capacity examination, hemolysis testing, and cytostatic activity suggest that LCC may be useful as a carrier of taxol.

Animals↗
PubMed1998

Effects of interleukin-1 receptor antagonist in a slow-release hylan vehicle on rat type II collagen arthritis.

PURPOSE: To determine the effect of hylan fluid (HA), a model slow release vehicle on the pharmacokinetic profile and efficacy of interleukin-1 receptor antagonist (IL-1ra) in rats with established type II collagen arthritis. METHODS: Female Lewis rats with type II collagen arthritis were treated daily, every other day or every third day with single subcutaneous (sc) injections of IL-1ra formulated in HA and the effects on arthritis determined. Results were compared to those obtained with IL-1ra in citrate buffered saline with EDTA and polysorbate (CSEP). Sequential blood levels were determined in rats injected sc with IL-1ra in CSEP or HA. RESULTS: Incorporation into HA led to slower release of IL-1ra into the bloodstream and maintained therapeutic blood levels of IL-1ra for a longer time compared to the IL-1ra/CSEP formulation. Single daily sc doses of 100 mg/kg IL-1ra in CSEP were ineffective in type II collagen arthritis. By contrast, once per day dosing of 100 mg/kg IL-1ra in HA provided 78% inhibition of paw swelling. Every other day dosing with 100 mg/kg IL-1ra in HA resulted in 62% inhibition. IL-1ra (100 mg/ kg in HA) given every third day provided 19% inhibition of arthritis. Improved efficacy correlated with improved pharmacokinetics. CONCLUSIONS: Administration of IL-1ra in the slow release vehicle HA improves pharmacokinetics and efficacy in rat type II collagen arthritis.

Animals↗
PubMed1989

Formulation of vaccine adjuvant muramyldipeptides. 3. Processing optimization, characterization, and bioactivity of an emulsion vehicle.

An efficacious vaccine adjuvant which elicits both cell-mediated immunity (CMI) and humoral immune response was developed using [thr1]-Muramyldipeptide (MDP) in an oil-in-water emulsion vehicle containing poloxamer 401, polysorbate 80, and squalane. Processing optimization was performed to increase the physical stability of this adjuvant emulsion which, when prepared by conventional mixing methods, demonstrated good bioactivity but poor physical stability. Various manufacturing methods were compared with a microfluidization process, which produced the most stable and elegant emulsion vehicle. The microfluidized emulsion also elicited equivalent biological response in the animal model tested.

Acetylmuramyl-Alanyl-Isoglutamine↗
PubMed1996

In vitro-in vivo myotoxicity of intramuscular liposomal formulations.

PURPOSE: The first objective was to study the in vitro myotoxicity of empty liposomes and to examine whether liposome size, charge and fluidity affect of liposomal myotoxicity. The second objective was to investigate the effect of liposomal encapsulation on the in vitro and in vivo myotoxicity of loxapine compared to the loxapine commercial preparation (Loxitane). METHODS: The in vitro myotoxicity of empty liposomes and loxapine liposomes was evaluated by the cumulative efflux of the cytosolic enzyme creatine kinase (CK) from the isolated rat extensor digitorum longus (EDL) muscle over a 2 hour period. In the in vivo studies, the area under plasma CK curve over 12 hours was used to evaluate muscle damage. RESULTS: The in vitro myotoxicity for all empty liposomal formulations was not statistically different from negative controls (untreated control muscles and normal saline injected muscles). However, these empty liposomal formulations were significantly less myotoxic than the positive controls (muscles injected with phenytoin and muscle sliced in half). In vitro-in-vivo studies showed that the liposomal encapsulation of loxapine resulted in significant (P < 0.05) reduction in myotoxicity (80% in vitro and 60% in vivo) compared to the commercially available formulation which contains propylene glycol (70% V/V) and polysorbate 80 (5% W/V) prepared at equal concentration. CONCLUSIONS: Results indicate that empty liposomes do not induce myotoxicity. Furthermore, liposomal size, charge and fluidity do not affect myotoxicity. In addition, in vitro and in vivo studies have demonstrated that liposomal encapsulation of loxapine can reduce myotoxicity compared to a formulation containing organic cosolvents.

Animals↗
PubMed1994

Intestinal permeability enhancement: efficacy, acute local toxicity, and reversibility.

The absorption of the polar drug phenol red was assessed in a rat intestinal perfusion model, in the presence of a variety of potential intestinal permeability enhancers. Both the absorption rate constant KA and the plasma phenol red concentration were measured. Perfusates were also assayed for the presence of lactate dehydrogenase (LDH) and lipid phosphate, as biochemical markers of intestinal wall damage. Histological evaluation of surfactant-perfused intestines was also carried out. The potential permeability enhancers studied were the surfactants sodium dodecyl sulfate (SDS), sodium taurocholate (TC), sodium taurodeoxycholate (TDC), polysorbate-80 (PS-80), and nonylphenoxypolyoxyethylene (NP-POE) with an average polar group size of 10.5 POE units. Among these, SDS and NP-POE-10.5 were the most potent permeability enhancers. The bile salt TDC was a more effective enhancer than the more polar TC. The polar non-ionic surfactant PS-80 was an ineffective enhancer. Phenol red KA and plasma level were generally correlated with biochemical and histological measures of intestinal damage. These observations indicate that permeability enhancement and local damage are closely related sequelae of the interaction of surfactants with the intestinal wall, and suggest that local wall damage may be involved in the mechanism of permeability enhancement. The reversibility of permeability enhancement and acute local damage was assessed for the surfactants TDC and NP-POE-10.5. Enhancement of phenol red permeability was reversed within 1-2 hr of the cessation of enhancer treatment. Biochemical markers of local damage also fell to control values within 1-2 hr of removal of enhancer from the perfusate. Histological evaluation of perfused intestines revealed that morphological damage was reversed within 3 hr. These results demonstrate that surfactant-induced acute intestinal wall damage is rapidly repaired.

Animals↗
PubMed2003

Effective inhibition of mannitol crystallization in frozen solutions by sodium chloride.

PURPOSE: The purpose of this work was to study the possibility of preventing mannitol crystallization in frozen solutions by using pharmaceutically acceptable additives. METHODS: Differential scanning calorimetry (DSC) and low-temperature X-ray diffractometry (LTXRD) were used to characterize the effect of additives on mannitol crystallization. RESULTS: DSC screening revealed that salts (sodium chloride, sodium citrate, and sodium acetate) inhibited mannitol crystallization in frozen solutions more effectively than selected surfactants, alpha-cyclodextrin, polymers, and alditols. This finding prompted further studies of the crystallization in the mannitol-NaCl-water system. Isothermal DSC results indicated that mannitol crystallization in frozen solutions was significantly retarded in the presence of NaCl and that NaCl did not crystallize until mannitol crystallization completed. Low-temperature X-ray diffractometry data showed that when a 10% w/v mannitol solution without additive was cooled at 1 degrees C/min, the crystalline phases emerging after ice crystallization were those of a mannitol hydrate as well as the anhydrous polymorphs. In the presence of NaCl (5% w/v), mannitol crystallization was suppressed during both cooling and warming and occurred only after annealing and rewarming. In the latter case however, mannitol did not crystallize as the hydrate, but as the anhydrous delta polymorph. At a lower NaCl concentration of 1% w/v, the inhibitory effect of NaCl on mannitol crystallization was evident even during annealing at temperatures close to the Tg' (-40 degrees C). A preliminary lyophilization cycle with polyvinyl pyrrolidone and NaCl as additives rendered mannitol amorphous. CONCLUSION: The effectiveness of additives in inhibiting mannitol crystallization in frozen solutions follows the general order: salts > alditols > polyvinyl pyrrolidone > alpha-cyclodextrin > polysorbate 80 approximately polyethylene glycol approximately poloxamer. The judicious use of additives can retain mannitol amorphous during all the stages of the freeze-drying cycle.

Calorimetry, Differential Scanning↗
PubMed2003

Predicting oral absorption of drugs: a case study with a novel class of antimicrobial agents.

PURPOSE: The purpose of this work was to evaluate an oral absorption prediction model, maximum absorbable dose (MAD), which predicts a theoretical dose of drug that could be absorbed across rat intestine based on consideration of intestinal permeability, solute solubility, intestinal volume, and residence time. METHODS: In the present study, Caco-2 cell permeability, as a surrogate for rat intestinal permeability, and aqueous solubility were measured for 27 oxazolidinones. The oxazolidinones are a novel class of potential antibacterial agents currently under investigation. These values were used to estimate MAD for each of the compounds. Finally, these predicted values were compared to previously measured bioavailability data in the rat in order to estimate oral absorption properties. RESULTS: A reasonably good correlation between predicted dose absorbed and bioavailability was observed for most of the compounds. In a few cases involving relatively insoluble compounds, absorption was underestimated. For these compounds while aqueous solubility was low. solubility in 5% polysorbate 80 was significantly higher, a solvent possibly more representative of the small intestinal lumen. CONCLUSIONS: These results suggest that MAD may be useful for prioritizing early discovery candidates with respect to oral absorption potential. In the case of compounds with poor aqueous solubility, additional factors may have to be considered such as solubility in the intestinal lumen.

Administration, Oral↗
PubMed2002

The association of airway hyperresponsiveness and tuberculin responses.

BACKGROUND: The balance between the two subsets of T cell is pivotal for allergic sensitization. OBJECTIVE: We conducted a cross-sectional study of 486 children vaccinated with bacillus Calmette-Guérin (BCG), aged 10-13 years, to evaluate whether tuberculin responses may contribute to airway hyperresponsiveness (AHR). METHODS: Tuberculin skin test, allergic skin test, and methacholine challenge test were done. The methacholine concentration causing a 20% fall (PC20) in forced expiratory volume in 1 second (FEV1) was used as a threshold of AHR. Atopy was defined as a reaction showing a mean wheal size of > or = 3 mm to one or more allergens on skin prick test (SPT). Two tuberculin units of polysorbate-stabilized purified protein derivatives (PPD) were injected intradermally into the volar surface of the forearm. Reactions were read at 48-72 h as the transverse diameter in millimeters of induration. RESULTS: Of the children in the study, 12.3% (60/486) had PPD induration; 7.8% (38/486) of children had PPD induration of greater than 10 mm. The PPD induration size was 10.5 +/- 1.03 mm (confidence interval (CI) 7.19-12.33) in atopic children and 11.2 +/- 0.76 mm (CI 7.89-13.1) in nonatopic children. The differences of PPD induration diameter between the two groups were not significant. There was no difference of log PC20 between PPD induration > or = 10 mm and < 10 mm (0.13 +/- 0.18 vs. 0.42 +/- 0.05). The difference of log PC20 between positive and negative tuberculin response was not significant. Children with atopy had lower log PC20 than those without atopy (0.16 +/- 0.07 vs. 0.51 +/- 0.05, P = 0.001). After adjusting for sex, age, height, weight, tuberculin response, atopy was associated with AHR in multivariate analyses (odds ratio = 1.895, CI 1.285-2.505, P = 0.002). CONCLUSION: These data suggested that a tuberculin response due to mycobacterial infection status have no effect on AHR in schoolchildren.

Adolescent↗
PubMed2003

Comparative pharmacokinetic study of high-dose etoposide and etoposide phosphate in patients with lymphoid malignancy receiving autologous stem cell transplantation.

The pharmacokinetics of two etoposide (E) formulations were evaluated in patients with refractory hematologic malignancies receiving high-dose conditioning with autologous stem cell transplantation. Patients were randomized to either E at 800 mg/m(2) (containing polysorbate 80 and polyethylene glycol) or etoposide phosphate (EP) at 910 mg/m(2) on days -7 and -5, prior to melphalan, 80 mg/m(2) on day -5. On day -3, EP was repeated. Plasma E was analyzed after each formulation on days -7 and -5 to compare intrapatient pharmacokinetics. In total, 10 patients were treated: four each with multiple myeloma or Hodgkin's disease and two with non-Hodgkin's lymphoma. Mucositis was the major toxicity with seven patients. EP first produced grade 3 mucositis. There was no procedure-related mortality and eight patients remained alive 1 year post-transplant. Cumulative etoposide exposure (AUC) was slightly greater with EP (P=0.056). Conversely, the volume of distribution was slightly, 33%, larger (P=0.052) and clearance was increased with the E infusion (P=0.14). As none of the differences reached statistical significance, both E formulations appear to be pharmacokinetically equivalent in the high-dose transplant setting. The combination of high-dose EP with melphalan is an active preparative regimen prior to ABMT for hematologic malignancies.

Adult↗
PubMed2002

Leaching of diethylhexyl phthalate from polyvinyl chloride bags into intravenous etoposide solution.

OBJECTIVE: To compare the release of diethylhexyl phthalate (DEHP) from polyvinyl chloride (PVC) bags from four different manufacturers into intravenous etoposide solutions. METHOD: Etoposide solutions, 0.4 mg/mL, containing the vehicle polysorbate 80 were prepared in 5% dextrose or 0.9% sodium chloride injection PVC bags and stored at room temperature for 24 h. DEHP content was analysed by high-performance liquid chromatography. RESULTS: Substantial amounts of DEHP (up to 20 microg/mL at room temperature) leached into the etoposide solutions. However, no significant differences were found in the amounts of DEHP leached into the etoposide infusion solutions prepared using either 5% dextrose or 0.9% sodium chloride injection and stored in the four different containers. CONCLUSION: To minimize patient exposure o DEHP, etoposide solutions should ideally be stored in a glass or polyolefin container.

Antineoplastic Agents, Phytogenic↗
PubMed2002

Allergic contact dermatitis to topical minoxidil solution: etiology and treatment.

After more than a decade of use, topical minoxidil solution has proven to be a safe and effective treatment for androgenetic alopecia. However, some patients present with complaints of pruritus and scaling of the scalp. The most common causes of these symptoms include irritant contact dermatitis, allergic contact dermatitis, or an exacerbation of seborrheic dermatitis. Patients suffering from allergic contact dermatitis may benefit from patch testing to determine the causative allergen. Among the patients we patch tested, propylene glycol was found to be the contactant in a majority of cases, not the minoxidil itself. Many of these patients may be candidates for treatment with alternative formulations using other solvents, such as butylene glycol, polysorbate, or glycerol. Although predictive, patch testing results do not ensure that the compounded preparations will be tolerated. Unfortunately, patients found to be allergic to minoxidil are no longer candidates for topical treatment of their alopecia with any preparations of minoxidil.

Administration, Topical↗
PubMed2002

Mechanical performance of knots using braided and monofilament absorbable sutures.

OBJECTIVE: The study was undertaken to test the integrity of various flat and sliding knots with the use of braided and monofilament absorbable sutures. STUDY DESIGN: There were four study groups, each of which consisted of a single suture type and size, with five different knots. Each combination was tested 10 times for a total of 200 experiments. The suture types used were 0-0 and 2-0 Glycomer 631 (Biosyn) and 0-0 and 2-0 coated Lactomer (Polysorb). Knots tested were the square knots, surgeon's knots, modified granny flat knots, and modified identical and nonidentical sliding knots. Knots were tested to failure with a tensiometer. We compared the proportion of knots becoming untied within each group and the ultimate load required to break tied knots. RESULTS: In the 0-0 and 2-0 Lactomer groups, 90% and 60% of modified identical sliding knots, respectively, became untied, significantly more than all other knots. CONCLUSION: When 0-0 and 2-0 Lactomer sutures were used, modified identical sliding knots should be avoided.

Absorption↗
PubMed2004

An improvement of double emulsion technique for preparing bovine serum albumin-loaded PLGA microspheres.

A modified double emulsion technique was adopted to prepare bovine serum albumin (BSA) loaded poly (D,L-lactic-co-glycolic acid) (PLGA) microspheres. In the formulations, polysorbates (Tween) such as Tween20, Tween40 or Tween80, instead of frequently used poly (vinyl alcohol) (PVA), was used as the emulsifier. Microspheres with porous surface, large particle size, low microsphere yield (approximately 65.4%) and BSA entrapment efficiency (approximately 25.2%) were obtained when Tween80 aqueous solution alone was used as the outer aqueous phase. However, microspheres with smooth surface, high yield and BSA entrapment efficiency could be produced successfully by introducing sodium chloride or glucose into the outer aqueous phase. Adding 5.0%(w/v) sodium chloride into the continuous phase led to increase in microsphere yield and BSA entrapment efficiency from 65.4% and 25.2% to approximately 100% and 76.6%, respectively. Microsphere yield and BSA entrapment efficiency increased from 64.5% and 25.2% to 97.2% and 89.3%, respectively, when 15.0%,(w/v) glucose was added into the continuous phase. In constrast to the microspheres prepared in the presence of additive, a more marked burst release was observed for microspheres prepared without additive in the continuous phase, which may be attributed to the porous morphology of the latter.

Animals↗
PubMed2006

Cytotoxicity of doxorubicin bound to poly(butyl cyanoacrylate) nanoparticles in rat glioma cell lines using different assays.

The cytotoxicity of doxorubicin bound to poly(butyl cyanoacrylate) nanoparticles (Dox-PBCA-NP) was investigated in the rat glioma cell lines GS-9L, F-98 and RG-2. MTT and LDH assays were used as cytotoxic assays. In general, the cytotoxicity of nanoparticle-bound doxorubicin (Dox) was enhanced compared to the free drug in solution. However, responses of the cell lines towards the drug effects were different. In the case of free Dox in solution, this difference correlated with different intracellular concentrations of Dox, which in turn, depended on the level of P-glycoprotein (P-gp) expression in these cell lines. Accordingly, the 9L gliosarcoma (GS-9L) cells, which appeared to be most resistant towards Dox, were characterized by the highest P-gp expression.Additionally, the influence of surfactants on the cytotoxic effect was investigated at different Dox concentrations. It was shown that the presence of polysorbate 80 (Tween 80) in the nanoparticle formulation significantly enhanced the cytotoxicity, whereas poloxamer 188 (Pluronic F68) and poloxamine 908 (Tetronic 908) had a negligible influence.

ATP Binding Cassette Transporter, Subfamily B, Mem↗
PubMed1999

Development of a topically active imiquimod formulation.

The purpose of this work was to develop a topical formulation of imiquimod, a novel immune response modifier, to induce local cytokine production for the treatment of external genital and perianal warts. A pH-solubility profile and titration data were used to calculate a pKa of 7.3, indicative of a weak base. Solubility experiments were conducted to identify a solvent that dissolves imiquimod to achieve a 5% formulation concentration. Studies to select surfactants, preservatives, and viscosity-enhancing excipients to formulate an oil-in-water cream indicated that fatty acids were the preferred solvent for topical imiquimod formulations, and isostearic acid (ISA) was selected. A relationship existed between the fatty acid composition of four commercially available ISA sources and the solubility of imiquimod. A combination of polysorbate 60, sorbitan monostearate, and xanthan gum was used to produce a physically stable cream. The preservative system included parabens and benzyl alcohol to meet the USP criteria for preservative activity. An in vitro method was developed to demonstrate that imiquimod was released from the formulation. Topical application of the formulation induced local cytokine activity in mice.

Adjuvants, Immunologic↗