Impact of structured physical therapy protocol among heart transplant recipients while on intra-aortic balloon pump in the pretransplant period.

BACKGROUND: Use of prolonged femoral intra-aortic balloon pump support limits the mobility of patients awaiting heart transplant. We assessed the safety and outcomes of a structured, tilting physical therapy protocol in patients supported by intra-aortic balloon pumps while awaiting transplant. METHODS: We retrospectively reviewed five years of transplant patients. Eighteen patients received femoral intra-aortic balloon support, a heart transplant, and met all eligibility criteria. We compared complications and outcomes between patients who received the structured, tilting physical therapy (Protocol Group) and those that received standard of care (Control Group). RESULTS: Complications were not significantly different between groups. The majority of the Protocol Group were discharged to home (10/12), while half (3/6) of the Control Group were discharged to a rehabilitation facility. Post-transplant length of stay was significantly less in the Protocol Group (median 16 vs. 28 days, p = 0.03). CONCLUSION: Despite the small number analyzed, the data indicates that the structured, tilting physical therapy protocol led to a significantly reduced length of stay post-transplantation. Importantly, use of the protocol did not result in access site complications, thrombosis, or arrhythmias in the majority of the patients.

Formulation of a novel fixed dose combination of salmeterol xinafoate and mometasone furoate for inhaled drug delivery.

Co-administration of an inhaled corticosteroid and long acting beta agonist for chronic obstructive pulmonary disease has reduced mortality compared to either drug alone. This combination reduces exacerbations, hospitalization, emergency department visits and health care costs. A novel fixed-dose combination of the long acting beta-2 agonist salmeterol xinafoate (SX) and the corticosteroid mometasone furoate (MF) were prepared in a composite particle formulation as brittle matrix powder (BMP) and investigated for suitability as an inhaled combination product. In this study, BMP fixed dose combinations of SX and MF with or without stabilizing excipients (lactose, mannitol, glycine and trehalose) were prepared and characterized with respect to their thermal properties, morphology, aerodynamic performance and physical stability. BMP combination formulations of SX and MF exhibited improved aerodynamic properties when delivered by dry powder inhalation as compared to the micronized blends of the same substances. Aerodynamic evaluation was carried out by next generation pharmaceutical impactor (NGI) with a marketed DPI device. Results demonstrated that co-deposition occurred when SX and MF were formulated together as composite particles in a BMP, while physical blends resulted in inconsistent deposition and dose uniformity. As a result of the bottom-up particle engineering approach, combination BMP formulations allow for dual API composite formulations to be dispersed as aerosolized particles. Aerosolized BMP combination formulations resulted in delivered dose uniformity and co-deposition of each API. Further, an excipient-free formulation, BMP SXMF, delivered approximately 50% of the loaded dose in the respirable range and demonstrated stability at ambient conditions for 6months. Single dose 24-h pharmacokinetic studies in rats demonstrated that lung tissue deposition and blood circulation (AUC0-24h) of two APIs were higher for the BMP combination group exhibiting a significantly higher lung concentration of drugs than for the crystalline physical blend. While high system drug levels are generally undesirable in lung targeted therapies, high blood levels in this rodent study could be indicative of increased pulmonary tissue exposure using BMP formulations.