Development and Characterizations of Pullulan and Maltodextrin-Based Oral Fast-Dissolving Films Employing a Box–Behnken Experimental Design

Migraine is a neurological disorder characterized by severe headaches, visual aversions, auditory, and olfactory disorders, accompanied by nausea and vomiting. Zolmitriptan (ZMT^®) is a potent 5HT1B/1D serotonin receptor agonist frequently used for the treatment of migraine. It has erratic absorption from the gastrointestinal tract (GIT), but its oral bioavailability is low (40–45%) due to the hepatic metabolism. This makes it an ideal candidate for oral fast dissolving formulations. Hence, the current study was undertaken to design and develop oral fast-dissolving films (OFDFs) containing ZMT for migraine treatment. The OFDFs were formulated by the solvent casting method (SCM) using Pullulan (PU) and maltodextrin (MDX) as film-forming agents and propylene glycol (PG) as a plasticizer. The strategy was designed using Box–Behnken experimental design considering the proportion of PU:MDX and percentage of PG as independent variables. The effectiveness of the OFDF’s was measured based on the following responses: drug release at five min, disintegration time (D-time), and tensile strength (TS). The influence of formulation factors, including percent elongation (%E), thickness, water content, moisture absorption, and folding endurance on ZMT-OFDFs, were also studied. The results showed a successful fabrication of stable ZMT-OFDFs, with surface uniformity and amorphous shape of ZMT in fabricated films. The optimized formulation showed a remarkable rapid dissolution, over 90% within the first 5 min, a fast D-time of 18 s, and excellent mechanical characteristics. Improved maximum plasma concentration (C max) and area under the curve (AUC 0–t) in animals (rats) treated with ZMT-OFDFs compared to those treated with an intra-gastric (i-g) suspension of ZMT were also observed. Copolymer OFDFs with ZMT is an exciting proposition with great potential for the treatment of migraine headache. This study offers a promising strategy for developing ZMT-OFDFs using SCM. ZMT-OFDFs showed remarkable rapid dissolution and fast D-time, which might endeavor ZMT-OFDFs as an auspicious alternative approach to improve patient compliance and shorten the onset time of ZMT in migraine treatment.     

Expedient approach for trans-esterification of β-keto esters under solvent free conditions using silica supported boric acid (SiO2–H3BO3) as a recyclable catalyst

A highly efficient trans-esterification of β-keto methyl/ethyl esters with primary, secondary, allylic, benzylic and chiral alcohols has been carried out in excellent yields under solvent-free conditions using silica supported boric acid as a heterogeneous catalyst. The surface morphology of the silica-boric acid catalyst (fresh and recycled) has been characterized by SEM and EDX techniques. This sustainable protocol resulted in a remarkable enhancement in the synthetic efficiency (87–95% yield) with high purity and eliminating the use of an environmentally toxic solvent. The work up procedure is very simple and the catalyst has been successfully recovered and recycled. The present methodology is also applicable for trans-esterification with chiral alcohols on a multi-gram scale without compromising the yield. Noteworthy features of this protocol are simple operational procedure, minimizing production of chemical waste, mild reaction conditions, easy preparation of the catalyst and its recyclability up to five cycles without any appreciable loss of catalytic activity.

A simple, mild, high yielding and minimizing chemical waste procedure for trans-esterification of β-keto methyl/ethyl esters with alcohol groups was developed under solvent-free condition using silica-boric acid as recyclable heterogeneous catalyst.     

Outpatient hysteroscopy and subsequent IVF cycle outcome: a systematic review and meta-analysis

A systematic review of studies evaluating the influence of outpatient (office) hysteroscopy on the outcome of the subsequent IVF cycle was conducted. MEDLINE, EMBASE, the Cochrane Library, National Research Register, ISI Conference Proceedings, ISRCTN Register and Meta-register were searched for randomized controlled trials (up to July 2007). All trials comparing the outcome of IVF treatment performed in patients who had outpatient hysteroscopy in the cycle preceding their IVF treatment with a control group in which hysteroscopy was not performed were included. Study selection, quality appraisal and data extraction were performed independently and in duplicate. Study authors were contacted for additional information. The main outcome measure was pregnancy rate. In total, 1691 participants were included in two randomized (n = 941) and three non-randomized controlled studies (n = 750). The quality of the studies was variable. Meta-analyses of the results of five studies showed evidence of benefit from outpatient hysteroscopy in improving the pregnancy rate in the subsequent IVF cycle (pooled relative risk = 1.75, 95% CI 1.51-2.03). The evidence from randomized trials was consistent with that from non-randomized controlled studies. Future robust randomized trials comparing outpatient hysteroscopy or mini-hysteroscopy with no intervention before IVF treatment would be a useful addition to further guide clinical practice.     

Diagnosing Periprosthetic Joint Infection: a Scoping Review

Purpose of ReviewThe goal of this review is to provide an up to date understanding of the utility and limitations of the current tests utilized in the diagnosis of periprosthetic joint infection (PJI) in total knee and hip arthroplasty.Recent FindingsDespite the growth in literature surrounding PJI diagnosis, there remains challenges in establishing a diagnosis of PJI. A combination of clinical, serum, and synovial tests and microbiologic and histologic examinations can yield a diagnosis in the majority of cases. Novel molecular and imaging studies may be beneficial for indeterminant cases. A number of emerging diagnostic tests have been proposed and may be incorporated into diagnostic algorithms in the future. Recently proposed stepwise diagnostic algorithms have shown high sensitivity and specificity.SummaryThe diagnosis of PJI remains challenging due to a lack of tests that can definitively rule out infection. Diagnosis and investigations should occur in a stepwise fashion. There has been a plethora of new diagnostic tests introduced in attempts to improve the accuracy of diagnostic algorithms. The definition and algorithms for the diagnoses of PJI will continue to evolve as new techniques and tests are introduced.     

Prophylaxis of thromboembolism in spinal injuries--survey of practice in spinal units in the British Isles

AIM: Survey and discussion of the current thromboembolic prophylaxis practice in spinal injury units within the British Isles. BACKGROUND: Deep vein thrombosis and pulmonary embolism are major causes of morbidity and mortality in patients with spinal injuries. A wide range of thromboprophylactic measures have been proposed. The optimum treatment and duration for thromboprophylaxis in spinal injuries is unknown. Different spinal units within the British Isles use different measures despite similar training backgrounds. The present study was performed to review practice and make suggestions on best practice using literature review. METHODS: All the 13 regional and national spinal injury referral centres within the British Isles were contacted to find out their protocols for thromboembolic prophylaxis in patients with acute spinal injuries. RESULTS: All units replied. A wide variation in methods used was found in different spinal units ranging from no chemical prophylaxis to oral anticoagulation with warfarin and contrasting views on the use of antithromboembolic stockings. CONCLUSION: All units recognised the risk of thromboembolism after spinal injuries. A wide variety of thromboprophylactic measures are used.     

Chest wall resections and reconstruction: a 25-year experience

Background. Chest wall defects continue to present a complicated treatment scenario for thoracic and reconstructive surgeons. The purpose of this study is to report our 25-year experience with chest wall resections and reconstructions.

Methods. A retrospective review of 200 patients who had chest wall resections from 1975 to 2000 was performed.

Results. Patient demographics included tobacco abuse, hypertension, diabetes mellitus, alcohol abuse, coronary artery disease, chronic obstructive pulmonary disease, and human immunodeficiency virus. Surgical indications included lung cancer, breast cancer, chest wall tumors, and severe pectus deformities. Twenty-nine patients had radiation necrosis and 31 patients had lung or chest wall infections. The mean number of ribs resected was 4 ± 2 ribs. Fifty-six patients underwent sternal resections. In addition 14 patients underwent forequarter amputations. Immediate closure was performed in 195 patients whereas delayed closure was performed in 5 patients. Primary repair without the use of reconstructive techniques was possible in 43 patients. Synthetic chest wall reconstruction was performed using Prolene mesh, Marlex mesh, methyl methacrylate sandwich, Vicryl mesh, and polytetrafluoroethylene. Flaps utilized for soft tissue coverage were free flap (17 patients) and pedicled flap (96 patients). Mean postoperative length of stay was 14 ± 14 days. Mean intensive care unit stay was 5 ± 9 days. In-hospital and 30-day survival was 93%.

Conclusions. Chest wall resection with reconstruction utilizing synthetic mesh or local muscle flaps can be performed as a safe, effective one-stage surgical procedure for a variety of major chest wall defects.