Bioequivalence Studies of Sildenafil Citrate Orodispersible Film Administered with and without Water vs ViagraⓇ Film-Coated Tablets in Healthy Male Volunteers.

Background: Orodispersible film (ODF) formulation offers ease of use, convenience of administration, and other advantages, especially for patients who have difficulty in swallowing or are on liquid restriction compared with conventional oral formulations for the treatment of erectile dysfunction. Objectives: These studies compared the bioequivalence of 50 mg sildenafil citrate ODF formulation (test drug) with the marketed 50 mg sildenafil citrate film-coated tablet (FCT) (ViagraⓇ; Pfizer, New York, NY) (reference drug), with and without water in 2 randomized cross-over studies. Methods: Two randomized cross-over studies were conducted. The first study explored the bioequivalence of test drug administered with and without water compared with the reference drug with water. The second study investigated the bioequivalence of test drug, without water, compared with the reference drug with water. Forty-two and 80 healthy male volunteers were recruited in the first and second study, respectively. All volunteers fasted for 10 hours pre-dose. A 1-day washout period between doses was observed. Blood samples were collected at both before (up to 120 minutes before dosing) and after dosing (at different intervals up to 14 hours) stages. Statistical analyses on pharmacokinetic parameters were performed. Safety and tolerability for both the formulations were evaluated. Results: In the first study, bioequivalence was demonstrated for sildenafil citrate ODF administered with water when compared with the ViagraⓇ FCT. The ratios of adjusted geometric means (90% confidence interval (CI)) were maximum plasma concentration: 1.02 (94.91-108.78) and area under the plasma concentration-time curve: 1.09 (104.49-113.21) for sildenafil citrate ODF administered with water vs ViagraⓇ FCT. These ratios were within the bioequivalence acceptance range of 80% to 125%, indicating that the bioequivalence criteria were met. The pharmacokinetic parameters for the second study also showed bioequivalence for sildenafil citrate ODF (without water) compared with ViagraⓇ FCT. The ratios of adjusted geometric means (90% CI) were maximum plasma concentration: 1.02 (95.47-109.36) and area under the plasma concentration-time curve: 1.06 (103.42-108.40) for sildenafil citrate ODF administered without water vs ViagraⓇ FCT. Adverse events in both the studies occurred at similar rates for the 2 formulations and were mild in intensity. Conclusions: These results suggest that the new ODF formulation can be used interchangeably with the marketed FCT formulation. Sildenafil citrate ODF administered with and without water met bioequivalence criteria compared with ViagraⓇ FCT administered with water under fasted conditions in healthy adult male volunteers. The new ODF formulation can be used as a suitable alternative to the conventional oral solid dosage form.

The Tactical Combat Casualty Care Casualty Card TCCC Guidelines ? Proposed Change 1301.

Optimizing trauma care delivery is paramount to saving lives on the battlefield. During the past decade of conflict, trauma care performance improvement at combat support hospitals and forward surgical teams in Afghanistan and Iraq has increased through Joint Trauma System and DoD Trauma Registry data collection, analysis, and rapid evidence-based adjustments to clinical practice guidelines. Although casualties have benefitted greatly from a trauma system and registry that improves hospital care, still lacking is a comprehensive and integrated system for data collection and analysis to improve performance at the prehospital level of care. Tactical Combat Casualty Care (TCCC) based casualty cards, TCCC after action reports, and unit-based prehospital trauma registries need to be implemented globally and linked to the DoD Trauma Registry in a seamless manner that will optimize prehospital trauma care delivery.

Oncologists and family physicians. Using a standardized letter to improve communication.

PROBLEM BEING ADDRESSED: Communication between oncologists at a regional cancer centre and family physicians caring for palliative cancer patients in the community was ineffective. OBJECTIVE OF PROGRAM: To improve communication between oncologists and family physicians by routine use of a template for dictated letters concerning follow-up care. PROGRAM DESCRIPTION: A consultation letter template was constructed and tested at a single clinic. The template was designed to guide oncologists dictating letters to family physicians for patients' follow-up visits. Effectiveness of the standardized letter was evaluated with a before-after survey. CONCLUSION: Using the template letter improved communication with respect to the relevance, timeliness, format, and amount of information. As care for patients at the end of life increasingly shifts to the community, ongoing efforts are required to improve communication between cancer centres and primary care physicians.