Browsing by Author "Foster, David R."

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    Effect of Gastric Fluid Volume on the in Vitro Dissolution and in Vivo Absorption of BCS Class II Drugs: A Case Study with Nifedipine
    (Springer, 2016-07) Nader, Ahmed M.; Quinney, Sara K.; Fadda, Hala M.; Foster, David R.; Department of Obstetrics and Gynecology, IU School of Medicine
    Nifedipine is a BCS Class II drug used for treatment of hypertension and preterm labor. Large inter-patient variability in nifedipine absorption results in variable exposure among different patients. We conducted in vitro dissolution studies to compare nifedipine dissolution from immediate release (IR) capsules with different volumes of dissolution media. Results from dissolution studies were used to design a crossover study in healthy volunteers to evaluate the effect of coadministered water volume with nifedipine 10 mg IR capsules on nifedipine pharmacokinetics, especially absorption (Cmax, tmax, and AUC0-6). Dissolution studies demonstrated that larger gastric fluid volumes result in enhanced nifedipine dissolution from 10 mg IR cosolvent capsules (73 vs. 17% in 200 and 100 mL simulated gastric fluid, respectively, at 30 min). The pharmacokinetic crossover study in healthy volunteers (N = 6) did not show a significant effect of the water volume administered with the capsule (50 vs. 250 mL) on Cmax, tmax, or AUC0-6 of orally administered nifedipine IR capsules (10 mg). However, administration of large water volumes resulted in lower variability in nifedipine Cmax (47 vs. 70% for 250 and 50 mL, respectively). Administration of large water volumes with nifedipine 10 mg IR cosolvent capsules may reduce inter-individual variability in plasma exposure. Evaluation of similar effects in other BCS Class II drugs is recommended.
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    A prospective analysis describing the innovative use of liposomal bupivacaine in burn patients
    (Elsevier, 2020-03) Boyd, Allison N.; Blair, Mary E.; Degenkolb, Kerri E.; Foster, David R.; Hartman, Brett C.; Sood, Rajiv; Walroth, Todd A.; Medicine, School of Medicine
    Burn patients frequently require autograft harvesting to facilitate wound healing, often resulting in significant pain. Liposomal bupivacaine is indicated for administration into a surgical site to produce postsurgical analgesia. The objective of this study was to evaluate efficacy, safety, and duration of postoperative analgesia with liposomal bupivacaine for donor site pain in burn patients. This was an observational, case–control study including adult patients with <20% total body surface area (TBSA) burned who received liposomal bupivacaine for postoperative pain management after autograft harvesting from lower extremity donor site(s). Patients from the case group were matched to historical control patients treated with traditional pain management. The primary outcome was the cumulative pain scores on postoperative day one measured by the area under the curve (AUC0–24). Secondary outcomes included AUC0–72, total milligram morphine equivalents (MME), length of stay, and adverse events. Data were collected in 36 patients who received liposomal bupivacaine, with 21 patients eligible for matching to historical controls. Patients included in the intervention and control groups were well-matched at baseline. Patients in the intervention group had a significantly lower median (IQR) AUC0–24 [578 (408,740) vs. 680 (544,803); p = 0.05] and shorter length of stay [4 days (1,9.5) vs. 6 days (318); p = 0.01]. No differences in adverse events related to the administration of liposomal bupivacaine or opioid-related adverse events were observed. Results indicate liposomal bupivacaine is safe and effective in burn patients. The results of this study add to the limited body of literature examining efficacy in this population.