Purpose: Spray-freeze drying (SFD) is a recently applied method to develop pharmaceutical powders. This study aimed to analyze the competence of Trehalose, Mannitol, Lactose, and Sorbitol instability and aerosolization of Immunoglobulin G (IgG) via SFD.
Methods: Induced soluble aggregates were quantified at 0 and 3?months, and 45?°C using size-exclusion chromatography. Conformation and thermogravimetric assessments were done by Fourier transform infrared spectroscopy and differential scanning calorimetry. Laser light scattering was performed to determine the particle sizes. Aerodynamic features were characterized by twin stage impinger and scanning electron microscopy.
Results: Although sugars/polyols preferably stabilized IgG following the process, storage stabilization was achieved in Trehalose, Trehalose-Lactose, Lactose, and Trehalose-Mannitol-based powders with soluble aggregates <5%. The conformation of antibody was preserved with β sheet content from 66.28% to 76.37%. Particle sizes ranged from 5.23 to 8.12?µm. Mannitol exhibited the best aerodynamic behavior, fine particle fraction (FPF: 70%) but high degree of protein aggregation during storage.
Conclusions: SFD could favorably stabilize antibody using Trehalose and its combination with Lactose and Mannitol, and also, Lactose alone. Sorbitol disturbed IgG powder recovery. Incorporation of other types of excipient is required for efficient respiratory delivery of IgG molecules. 相似文献
Although the rate of patients reporting satisfaction is generally high after joint replacement surgery, up to 23% after total hip replacement and 34% after total knee arthroplasty of treated subjects report discomfort or pain 1 year after surgery. Moreover, chronic or subacute inflammation is reported in some cases even a long time after surgery. Another open and debated issue in prosthetic surgery is implant survivorship, especially when related to good prosthesis bone ingrowth. Pulsed Electro Magnetic Fields(PEMFs) treatment, although initially recommended after total joint replacement to promote bone ingrowth and to reduce inflammation and pain, is not currently part of usual clinical practice. The purpose of this review was to analyze existing literature on PEMFs effects in joint replacement surgery and to report results of clinical studies and current indications. We selected all currently available prospective studies or RCT on the use of PEMFs in total joint replacement with the purpose of investigating effects of PEMFs on recovery, pain relief and patients' satisfaction following hip, knee or shoulder arthroplasty. All the studies analyzed reported no adverse effects, and good patient compliance to the treatment. The available literature shows that early control of joint inflammation process in the first days after surgery through the use of PEMFs should be considered an effective completion of the surgical procedure to improve the patient's functional recovery. 相似文献
IntroductionThe liver is the most frequently damaged organ in blunt abdominal trauma. It is widely accepted that hemodynamically stable patients with low-grade liver trauma should be treated with non-operative management, however there is controversy surrounding its safety and efficacy in high-grade trauma. The purpose of this review is to investigate the role of non-operative management in patients with high-grade liver trauma.MethodsPubMed and reference lists of PubMed articles were searched to find studies that examined the efficacy of non-operative management in high-grade liver injury patients, and compare it to operative management. Non-operative management was considered successful if rescue surgery was avoided. Outcomes considered were success, mortality, and complication rates.ResultsThe electronic search revealed 2662 records, 8 of which met the inclusion criteria. All 8 studies contained results suggesting that non-operative management was safe and effective in hemodynamically stable patients with high-grade liver trauma. By combining the outcomes of the different studies, non-operative management had a high success rate of 92.4% (194/210) in high-grade liver trauma patients, which was near the overall 95.0% non-operative management success rate. Non-operative management also had mortality and complication rates of 4.6% (9/194) and 9.7% (7/72) in high-grade injury patients, respectively, compared to operative management's 17.6% (26/148) and 45.5% (5/11).ConclusionNon-operative management of liver trauma is safe and effective in hemodynamically stable patients with high-grade liver injury. It is associated with significantly lower mortality compared with operative management. More studies are required to evaluate complications of non-operative management in high-grade liver injury. 相似文献
PURPOSE: The purpose of this study was to measure spectrophotometrically the color stability of pigmented A-2186 silicone maxillofacial elastomer with 10% by volume of titanium white dry earth opacifier before and after exposure to microwave energy over a simulated 1.5-year period of microwave sterilization. Materials AND METHODS: A-2186 silicone elastomer opacified with titanium white dry earth pigment, pigmented with 5 cosmetic dry earth pigment colors [no pigment (control) group (Pc), red (Pr), yellow ochre (Py), burnt sienna (Po), and a mixture of Pr + Py + Po color group (P3)], was used in this study. Each of the 5 experimental groups consisted of 5 specimens. All specimens were placed in a 250 ml glass beaker filled with 150 ml of water (replenished for each microwave exposure). An exposure of 6 minutes was used 18 times (simulating 1.5 years of microwave sterilization with one 6 minute exposure monthly). Reflectance values were measured by spectrophotometer. Three- and two-way analyses of variance with repeated measures were performed for the color difference (DeltaE*) with the factors of group/color/months, and group/months, respectively. Means were compared by Tukey Honest Significant Difference (HSD) multiple range test calculated at the 0.05 level of significance using SPSS. RESULTS: The trained human eye can detect color changes (DeltaE*) greater than 1.0. Most DeltaE* values of the red pigment group at all intervals and the mixed pigment group at 15- and 18- month intervals increased significantly greater than 1.0 (p < 0.001) compared with the control group. Yellow and burnt sienna groups remained the most color stable over time with DeltaE* values below 0.35. CONCLUSIONS: Lack of color stability of red dry earth pigmented A-2186 silicone maxillofacial elastomers was clinically significant after 12-month exposure to microwave energy as compared with yellow, burnt sienna, and opacified A-2186 dry earth pigments. 相似文献