Patients' perspectives of fast-track surgery and the role of the fast-track clinical nurse consultant in gynecological oncology.

This study examines the role of the fast-track nurse in gynecology from a patient perspective. The fast-track nurse is a specialist nursing role, which coordinates patient care, in addition to providing specialized clinical care. Semistructured interviews were conducted with women who had fast-track surgery for gynecological cancer.

Patients' satisfaction with fast-track surgery in gynaecological oncology.

This study investigates the experience and satisfaction with care of fast-tracked gynaecological patients. The Sydney Gynaecological Oncology Group, New South Wales, Australia, has previously shown the benefits of a fast-track surgery programme for gynaecology patients with both complex benign gynaecological pathology and gynaecological malignancy. The question of whether these benefits translate into a positive experience for fast-tracked patients, in the context of their hospital stay and healthcare team care, has not been previously explored in detail. A self-administered satisfaction questionnaire incorporating the European Organisation for Research and Treatment of Cancer (EORTC) cancer in-patient satisfaction with care measure (INPATSAT-32) questionnaire with additional questions was administered to 106 gynaecology participants at Royal Prince Alfred Hospital. Participants reported high levels of satisfaction with patient care and support received from doctors, ward nurses and the hospital as a service and care organisation, within the context of a fast-track surgical programme. Early hospital discharge after gynaecological surgery results in both enhanced recovery after surgery (ERAS) and high levels of patient satisfaction.

Epstein-Barr virus-associated smooth muscle tumour presenting as a parasagittal brain tumour.

Dural-based brain tumours, apart from meningiomas, are rare. Epstein-Barr virus (EBV)-associated smooth muscle tumor (SMT) is a documented but rare disease that occurs in immunocompromized patients. These tumours may be located at unusual sites including the brain. We present a 37-year-old patient, positive for the human immunodeficiency virus (HIV), who was admitted after generalized tonic-clonic seizures. MRI and CT scan revealed a dural-based brain tumour, intraoperatively thought to be a meningioma, but with an eventual histological diagnosis of EBV-SMT. Clinically the patient was well postoperatively with a Glasgow coma scale score of 15/15 and no focal neurologic deficit. This case confirms the association between EBV and SMT in patients with HIV/acquired immunodeficiency syndrome (AIDS). It also highlights the need to include EBV-SMT in the differential diagnosis of intracranial mass lesions in patients with HIV/AIDS.

Porcine buccal mucosa as an in vitro model: relative contribution of epithelium and connective tissue as permeability barriers.

Porcine buccal mucosa has been extensively used as an in vitro model to study the permeability of various diffusants and to assess their potential to be delivered through the buccal route. The relative contribution of each component of the buccal mucosa on drug permeability was assessed in this study. The permeability of model diffusants decreased significantly with an increase in the mucosal thickness. A bilayer membrane model was developed to delineate the relative contribution to the barrier function offered by the epithelium and the connective tissue region. The decrease in permeability with mucosal thickness was attributed to the increase in the thickness of connective tissue. However, the epithelium acted as a primary barrier to permeation of all diffusants studied at a mucosal thickness up to 500 microm. In addition, the epithelium exhibited higher resistance to the permeation of hydrophilic diffusants than to lipophilic diffusants. With an increase in buccal mucosal membrane thickness, the lag time for the diffusants increased. Based on the analysis of permeation data, the buccal membrane, as a composite of epithelium and connective tissue, is considered as a heterogeneous permeation barrier. A mucosal tissue thickness of about 500 microm is recommended for in vitro transbuccal permeation studies since the epithelium remained the major permeability barrier for all diffusants at this thickness.

Current status and the future of buccal drug delivery systems.

BACKGROUND: The delivery of drugs through the buccal mucosa has received a great deal of attention over the last two decades, and yet there are not many buccal delivery products available on the market. OBJECTIVE: This review outlines the advantages and disadvantages of buccal drug delivery, provides a historical perspective and discusses representative developmental and marketed drugs. METHODS: The structure of the oral mucosa is briefly described to preface a description of the pathways for drug absorption and a critical discussion of permeation experiments. A brief historical perspective followed by a description of some of the currently marketed products provides a picture of where we are today. An indication is given of likely progress in this area and of the attributes of a successful business entity of the future. CONCLUSION: The authors provide an assessment of the future potential of buccal and sublingual drugs.

Clear-cell cancer of the ovary-is it chemosensitive?

The records of all patients with clear-cell ovarian cancer (CCC) who underwent complete surgical staging and chemotherapy between 1984 and 2001 were reviewed and 39 patients identified as suitable for study. The mean patient age was 56 years, and the stage distribution was as follows: stage I, 53%; stage II, 13%; stage III, 32%; and stage IV, 2%. One in three patients with stage I disease developed recurrent disease despite adjuvant chemotherapy. Seventy percent of tumors demonstrated a response to combination carboplatin and paclitaxel. Tumors which had either a partial response or failed to respond to first-line chemotherapy demonstrated no response to second-line nonplatinum chemotherapy. Endometriosis was identified in 31% of tumors, and 18% of patients developed deep venous thrombosis (DVT); however, neither endometriosis nor DVT was associated with a poorer outcome. CCC has a high recurrence rate in early-stage disease despite adjuvant treatment with cytotoxic chemotherapy. Advanced disease does respond to carboplatin and paclitaxel, which should be the chemotherapeutic regimen of choice. New second-line agents are urgently required.

Fine-Particle ethylcellulose as a tablet binder in direct compression, immediate-release tablets.

Ethylcellullose has traditionally been used in tablets as a binder in an alcohol solution form. In the present study, fine-particle ethylcellulose (FPEC) was used as a binder to manufacture immediate-release tablets by the direct compression technique. The binding potential of FPEC is compared to that of commercially available coarse-particle ethylcellulose at the same viscosity grade and to that of hydrophilic binders. The compression force setting was kept constant for all batches. The concentration of the binder was varied from 5% to 25%. Acetaminophen was used as a model drug because capping is a problem frequently observed during high-speed compaction and further processing of acetaminophen tablets. In this study, there would be an increase in the contact area with FPEC and hence greater bond formation. This greater bond formation should be able to reduce the problem of capping in tablets containing highly elastic materials such as acetaminophen. Tablets were evaluated based on the following tests: weight variation, extent of capping, hardness, friability, disintegration, and dissolution. Based on the results of these tests, FPEC proved to be an effective binder for directly compressed acetaminophen tablets. The 10% and 15% formulations of FPEC passed all the tests and also produced the hardest tablets.

Isolated Langerhans cell histiocytosis of the vulva: a case report.

We present a case of isolated vulval Langerhans cell histiocytosis (LCH) that was initially treated with an excision biopsy but recurred 2 months later. Local vulval radiotherapy resulted in complete resolution of the lesion and there was no evidence of recurrence after 24 months of follow-up.

Passive ileal segment urinary diversion in advanced cervical carcinoma--a retrospective review.

OBJECTIVES: Urinary diversion is a clinical management option that gynaecological oncologists often use for urinary fistulas associated with cervical cancer. We retrospectively reviewed the indications and postoperative morbidity and mortality associated with this procedure. METHODOLOGY: The case records of all patients with cervical carcinoma undergoing a passive ileal segment urinary diversion at King Edward VIII Hospital in Durban between 1 January 1991 and 31 December 1995 were reviewed retrospectively. The patient profile, indication for the operation and postoperative morbidity and mortality were noted. RESULTS: Sixty-five patients were entered into the study. Thirty-two patients (49%) had untreated advanced cervical carcinoma, 12 (19%) had had prior palliative irradiation for cervical carcinoma and 21 (32%) had received prior radical radiotherapy for cervical carcinoma. Fifty per cent of patients experienced significant postoperative morbidity. This was especially high in those patients who had received prior radical radiotherapy (67%). Twelve patients (19%) died before discharge. Six (50%) of those who had received prior radical radiotherapy died following the procedure. Advanced age (more than 65 years), previous radical radiotherapy, extrapelvic metastatic carcinoma and re-laparotomy for complications of the procedure were significant risk factors for postoperative mortality in our study. CONCLUSION: Careful patient selection, the use of bowel free of radiation injury, supportive management of postoperative complications and the establishment of a specific unit of trained staff are essential in order to ensure a successful outcome in patients undergoing this procedure.

Evaluation of a novel, natural oligosaccharide gum as a sustained-release and mucoadhesive component of calcitonin buccal tablets.

The objective of this study was to evaluate the gum from Hakea gibbosa (hakea) as a sustained-release and mucoadhesive component in buccal tablets for a model peptide, namely, salmon calcitonin. Flat-faced core tablets containing either 12 or 32 mg of hakea and 40 microg (200 IU) of salmon calcitonin (sCT) per tablet were formulated using a direct compression technique and were coated with Cutina on all but one face. The in vitro release profiles were sigmoidal in nature and according to a mathematical model indicated super Case II transport as the primary mechanism of release. The resulting plasma sCT and calcium concentrations were determined following both intravenous administration and buccal application of mucoadhesive tablets in rabbits. Following intravenous administration, the mean values determined for t(1/2) (alpha), t(1/2) (beta), V(d), and CL for sCT were 0.76 +/- 0.06 min, 67 +/- 18 min, 1484 +/- 454 mL/kg, and 19 +/- 2 mL/min.kg, respectively. Following the application of the mucoadhesive buccal tablets which contained 40 microg of sCT and either 12 or 32 mg of hakea, the calculated apparent bioavailability (F) and clearance (CL) were 37 +/- 6% and 19 +/- 3.3 mL/min.kg and 16 +/- 8% and 18 +/- 0.4 mL/min. kg, respectively. Serum calcium concentrations indicated that biologically active sCT was delivered across the rabbit buccal mucosa. The strength of mucoadhesion of the tablets was also quantitated in terms of the force of detachment as a function of time. The force of detachment for the mucoadhesive buccal tablets containing either 12 or 32 mg of hakea and 40 microg of sCT increased from 4.47 +/- 0.68 to 8.41 +/- 1.0 N and 8.23 +/- 1.62 to 14.98 +/- 1.63 N, respectively, from 5 to 90 min following application to excised rabbit intestinal mucosa. These results demonstrate that the novel, natural gum from Hakea gibbosa may be used to sustain the release of sCT from a unidirectional-release buccal tablet. The mechanism of in vitro release is likely to involve peptide diffusion/polymer dissolution. The mucoadhesive strength, as measured by the force of detachment, can be modulated by altering the amount of hakea in the tablet. The mucoadhesive buccal tablets described in this paper represent an improved transbuccal delivery system for therapeutic polypeptides.

Transmucosal sustained-delivery of chlorpheniramine maleate in rabbits using a novel, natural mucoadhesive gum as an excipient in buccal tablets.

The objective of this study was to evaluate the gum from Hakea gibbosa (Hakea) as a sustained-release and mucoadhesive component in buccal tablets following their application to the buccal mucosa of rabbits. Flat-faced core tablets containing either 22 or 32 mg of Hakea and 40 or 25 mg of chlorpheniramine maleate (CPM) per tablet with either sodium bicarbonate or tartaric acid in a 1:1.5 molar ratio were formulated using a direct compression technique and were coated with Cutina(R) on all but one face. The resulting plasma CPM concentration versus time profiles were determined following buccal application of the tablets in rabbits. The strength of mucoadhesion of the tablets was also quantitated in terms of the force of detachment as a function of time. Following the application of the mucoadhesive buccal tablets, the following values for several pharmacokinetic parameters were obtained. The force of detachment for the mucoadhesive buccal tablets containing 22 mg of Hakea and either 25 and 40 mg CPM, and 32 mg Hakea and 40 mg CPM increased from 1.64+/-0.47 to 7.32+/-0.34 N, 1.67+/-0.30 to 7.21+/-0.36 N, and 2.93+/-0.73 to 7.92+/-0.60 N, respectively from 5 to 90 min following application to excised intestinal mucosa. Addition of either sodium bicarbonate or tartaric acid, as well as higher amounts of CPM, did not affect the mucoadhesive bond strength. These results demonstrate that the novel, natural gum, H. gibbosa, may not only be used to sustain the release of CPM from a unidirectional-release buccal tablet, but also demonstrate that the tablets are sufficiently mucoadhesive for clinical application. The mucoadhesive strength as measured by the force of detachment, can be modulated by altering the amount of Hakea in the tablet. The mucoadhesive buccal tablets evaluated represent an improved transbuccal delivery system for conventional drug substances.

Evaluation of the gum from Hakea gibbosa as a sustained-release and mucoadhesive component in buccal tablets.

The objective of this paper was to evaluate the mucoadhesive and sustained-release properties of the water-soluble gum obtained from Hakea gibbosa (hakea), for the formulation of buccal tablets. Flatfaced tablets containing hakea were formulated using chlorpheniramine maleate (CPM) as a model drug. Two types of tablets were prepared: uncoated tablets (type I) and tablets in which all but one face of the type I tablet was coated with hydrogenated castor oil (Cutina) using a compression coating technique (type II). In an attempt to explain the observed sustained-release effect, the potential for a chemical interaction between hakea and CPM was evaluated by FTIR, differential scanning calorimetry (DSC), UV spectroscopy, and acid-base titrations. Mathematical modeling of the CPM release data was developed to elucidate the mechanism of drug release. The mucoadhesive strength was evaluated by quantitating the force of detachment. Finally, the rates of water uptake and erosion were determined for the buccal tablets. The time required for 90% of the CPM to be released in vitro (t90%) was used as a basis for comparison. For formulations that did not contain hakea, the t90% was 14 min for both directly compressed and wet granulated tablets, whereas the t90% for wet granulated tablets containing 2 or 32 mg hakea/tablet was 36 and 165 min, respectively. Directly compressed tablets containing 2, 12, 22, and 32 mg hakea/tablet displayed t90% values of 48, 120, 330, and 405 min, respectively. DSC, FTIR, UV spectroscopy and acid-base titration experiments suggested the absence of chemical interactions. The force of detachment for directly compressed and wet granulated tablets increased from 0.70 +/- 0.3 to 4.08 +/- 0.52 N and from 0.65 +/- 0.28 to 3.94 +/- 0.31 N as the amount of hakea per tablet was increased from 0 to 32 mg, respectively, at a 5 N attachment compression force. The novel natural gum, hakea, may not only be utilized to sustain the release of CPM from a unidirectional-release buccal tablet, but it also exhibited excellent mucoadhesive properties. The mechanism by which CPM release was sustained was more likely due to slow relaxation of the hydrated hakea. The mucoadhesive strength can be modulated by altering the amount of hakea in the tablet.

A comparison of two quality assessment methods for emulsions.

A common method of assessing the quality of emulsions is to evaluate the size distribution of the globules of the internal phase. The primary aim of this work is to compare the sensitivity of this test to an alternative method. The sizes of the globules of two emulsions, an oral emulsion and a total parenteral nutrition (TPN) emulsion, were determined using a light microscope. Globule size analyses were performed upon preparation and during storage of the emulsions. Using a computer program specially developed for this study, the recorded diameters were placed into size groups and the volumes of each of the measured globules was determined. For each size group, the total volume of all the globules within the group and the volume percentage of the oil phase represented by the group were calculated. The volume distribution of the internal phase across the size groups was found to predict emulsion instability better than the globule number distribution and thus is a better determinant of emulsion quality. This technique may have general application in the evaluation of TPN emulsions and other spheres, such as liposomes.