Development and in vitro/in vivo evaluation of dihydroergotamine mesylate loaded maltodextrin-pullulan sublingual films.

Dihydroergotamine mesylate (DHE), ergotamine derivative, has been offered for clinical use to stop or treat symptoms of an emerging migraine as injection for more than a half century. It is shown that bioavailability of DHE greatly changes between the subjects and up to 99% of the orally absorbed dose may be cleared by first pass metabolism. The aim of this study was to design and optimize DHE fast-dissolving sublingual films for migraine treatment. For this purpose pullulan and maltodextrin was chosen as film-forming polymers and propylene glycol as plasticizer. For optimization process Box Behnken design was used. The formed films were free from air bubbles, cuttings, or cracks. Disintegration, mechanical strength and dissolution of films were compared. It is found that pullulan and maltodextrin formed films with the most desired properties at the concentration of 1.5% and 2%. The application of optimum formulation to rabbits showed that bioavailability of formulation is about 23.35% with a tmax 20 min. Due to this fast onset of action and higher bioavailability than oral administration, it is suggested that the polymer combinations of pullulan and maltodextrin formed successful films and were considered as an alternative dosage form for DHE in migraine therapy.

Evaluation of a novel oxiconazole nitrate formulation: The thermosensitive gel.

Superficial fungal infections caused by Candida species are common skin diseases. Therefore, this study aimed to develop a new formulation containing oxiconazole nitrate, which is an azole group derivative for antifungal treatment, as a thermosensitive gel since there has been no literature study until now. MIC value of the novel thermosensitive formulation against three Candida species was calculated and time-dependent antifungal activity analysis was performed. Viscosity, transition temperature Tsol-gel (°C) and gelation time of the thermosensitive gel formulation were also determined in the viscometer. The measurements performed on the tensilometer device were analyzed for adhesion hardness and elongation percentages of the formulation. In the FT-IR spectrometer, the spectrum of solution and gel state was compared between 650 and 4000 cm-1 and it was found that there is no difference between them. It was found that the temperature is reversible on the formulation and did not cause any disruption of its components. Characterization parameters of the thermosensitive gel formulation containing oxiconazole nitrate and time-dependent activity against Candida species was observed to be the same as those of the solution containing only oxiconazole nitrate. MIC, MFC and time-dependent antifungal analysis did not show any particular difference between formulation and oxiconazole nitrate itself. Thermosensitive gel formulation containing oxiconazole nitrate was found to be effective on superficial fungal infections. We believe it is also appropriate for in vivo usage, but it is necessary to perform animal and human research. It is also needed to evaluate the formulation against other etiologic agents of superficial fungal infections.

Treatment of chronic inflammatory demyelinating polyneuropathy with high dose intravenous methylprednisolone monthly for five years: 10-Year follow up.

OBJECTIVE: Although various modalities of treatment of chronic inflammatory demyelinating polyradiculopathy (CIDP) there are not any treatment protocol agreed. MATERIALS AND METHODS: We retrospectively evaluated the 20 CIDP patients (14 male, 6 female). Five patients were excluded from the study because they could not continue their treatments due to various problems during the treatment. The remaining 15 patients treated with monthly high dose intravenous methyl prednisolone for five years (IVMP) and followed up for 10 years. RESULTS: The mean age of the patients was 48.1±14.6 years. The mean duration of disease was 6.8±3.1 years. We were found statistically significant difference between the pre-treatment and sixth month modified Rankin scores (p<0.001). Similarly, significant improvement was observed at the end of first, fourth and fifth years of treatment. Statistically significant difference was found between baseline and tenth year modified Rankin scores of 12 patients who were treated with only IVMP during 10 years follow-up. CONCLUSION: Long-term monthly IVMP pulse therapy seems to be very effective in the treatment of CIDP.

Successful management of bleeding after dental procedures with application of blood stopper: a single center prospective trial.

AIM: Ankaferd Blood Stopper (ABS), as an herbal complementary medicine, has been approved for the management of clinical hemorrhages in Turkey, including dental interventions. Basic, preclinical and clinical studies disclosed the settings of the topical hemostatic use of ABS. The aim of this study is therefore to assess the efficacy and safety of ABS as an antihemorrhagic agent in the bleedings associated with dental procedures in patients with normal and impaired hemostasis. MATERIALS AND METHODS: ABS has been topically applied by homogeneously spraying to the 113 patients during dental interventions within its on-label indications. A median of 0.5 ml (IQR:0.5-1 ml) ABS was administered after tooth extraction with prolonged hemorrhages. RESULTS: After the administration, bleeding stopped in less than 10 seconds in 59 (52.2%) patients, and below 22.5 seconds (IQR: 18, 8-30) in 54 patients (47.8%). A total of 141 procedures were performed in these 113 patients, and nearly 72.5 ml ABS was used with a total cost of 98 €. CONCLUSION: ABS as a new herbal medicine was found to be an effective method for controlling bleeding related to dental procedures. No patient had wound infection and the healing process appeared to be normal. Topical ABS could be useful for the local hemostasis and wound healing in periodontal surgeries. CLINICAL SIGNIFICANCE: In this prospective study ABS, for the first time, has demonstrated its potential for being an effective hemostatic agent for the management of bleedings due to dental procedures.