Controlled porosity‐osmotic pump pellets of a poorly water‐soluble drug using sulfobutylether‐β‐cyclodextrin, (SBE)7M‐β‐CD, as a solubilizing and osmotic agent

Sotthivirat, Sutthilug; Haslam, John L.; Stella, Valentino J.

doi:10.1002/jps.20891

Cited by 23 publications

(15 citation statements)

References 31 publications

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“…Thus, in addition to their use as solubilizers and stabilizers, Professor Stella also suggested their use as osmotically active agents in oral osmotic pumps. This innovation means that the sulfobutyl cyclodextrins could serve the dual roles of drug solubilizer and osmogen used to drive the drug from the device 13…”

Section: Fields Of Researchmentioning

confidence: 99%

Effects of supportive‐expressive group therapy on survival of patients with metastatic breast cancer: A randomized prospective trial

Kissane¹,

Li²

2007

Cancer

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B ased on a very small subsample of 25 estrogen receptor (ER)-negative women with breast cancer, 13 of whom received group therapy, Spiegel et al. 1 conducted an exploratory analysis that found increased survival for these women. They have argued that these women were not protected by hormonal therapies.In our much larger Australian study of group therapy with women with advanced breast cancer, there were 70 ER-negative women. 2 Kaplan-Meier survival analysis showed no difference between the 43 hormone receptor-negative (estrogen) patients in the group intervention condition and the 27 hormone receptor-negative patients in the control condition. The median survival durations were at 15.5 months (95% confidence interval [CI], 9.5-25.8) for patients in the intervention condition and 17.2 months (95% CI, 8.1-26.5) for patients in the control condition, respectively. The logrank test for equality of survivor functions was not statistically significant (chi-square (2) ¼ 0.55, P ¼ .46).We also tried to replicate their analytic method exactly. In a Cox proportional hazards model we tested the effect of a treatment by positive hormone receptor status interaction, after controlling for intervention site, intervention site by treatment interaction, a treatment main effect, and a positive hormone receptor status main effect. We also centered the predictors as recommended in Kraemer and Blasey, 3 with coding of 1/2 and À1/2 in dichotomous variables (for both the randomization and hormone receptor status variables) and 1-1/m and À1/m for the site dummy variables (where m ¼ 5 in our study). Again, the result was consistent with the Kaplan-Meier survival analysis. There was no hormone receptor status by treatment interaction (Cox proportional hazards B ¼ 1.14, Wald statistic ¼ 0.38, P ¼ .71).Given our inability to replicate their latest exploratory finding, we conclude that it is a chance finding. Women should not be swayed into false hope, but appreciate that strong evidence has emerged that group therapy does not prolong survival. Group therapy does prevent depression and improve quality of life, thus representing a wonderful adjunctive psychosocial treatment for those with cancer. REFERENCES

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Section: Fields Of Researchmentioning

confidence: 99%

Effects of supportive‐expressive group therapy on survival of patients with metastatic breast cancer: A randomized prospective trial

Kissane¹,

Li²

2007

Cancer

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“…Further details of the formulation development can be found in a separate report, while the work presented here relates to the physical characterization of PDL in these formulations, which can be used to explain in vitro performance of the pellet formulations. 10 PDL has an intrinsic solubility of 0.21 AE 0.01 mg/mL in water at 258C. Its solubility is significantly enhanced with CD by forming a 1:1 complex, with a binding constant of 1691 AE 98/M, determined using a UV method where the drug and complexed drug have different UV absorption properties.…”

Section: Introductionmentioning

confidence: 99%

Characterization of Prednisolone in Controlled Porosity Osmotic Pump Pellets using Solid-State NMR Spectroscopy

Sotthivirat

Lubach

Haslam³

et al. 2007

Journal of Pharmaceutical Sciences

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“…2) were chosen because some showed poor binding with previous CD derivatives. There is also interest in increasing the solubility of steroids as well as other drug molecules and their use in controlled release osmotic pump tablets and pellets 8, 9. Additionally, dihydropyridine calcium channel blockers (Fig.…”

Section: Introductionmentioning

confidence: 99%

Sulfobutyl ether-alkyl ether mixed cyclodextrin derivatives with enhanced inclusion ability

Tongiani

Ozeki

Stella

2009

Journal of Pharmaceutical Sciences

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Controlled porosity‐osmotic pump pellets of a poorly water‐soluble drug using sulfobutylether‐β‐cyclodextrin, (SBE)7M‐β‐CD, as a solubilizing and osmotic agent

Cited by 23 publications

References 31 publications

Effects of supportive‐expressive group therapy on survival of patients with metastatic breast cancer: A randomized prospective trial

Effects of supportive‐expressive group therapy on survival of patients with metastatic breast cancer: A randomized prospective trial

Characterization of Prednisolone in Controlled Porosity Osmotic Pump Pellets using Solid-State NMR Spectroscopy

Sulfobutyl ether-alkyl ether mixed cyclodextrin derivatives with enhanced inclusion ability

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