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The present study compared in a clinical non-experimental setting the efficacy of buprenorphine (BUP) and methadone (METH) in the treatment of opioid dependence: all the subjects included in the study showed severe long-lasting heroin addiction. Participants (154) were applicants to a 12 weeks treatment program, who were assigned to either METH (78) (mean doses 81.5 +/- 36.4 mg) or BUP (76) (mean doses 9.2 +/- 3.4 mg) treatment. Aim of the study was to evaluate patient/treatment variables possibly influencing retention rate, abstinence from illicit drugs and mood changes. METH patients showed a higher retention rate at week 4 (78.2 versus 65.8) (P < 0.05), but BUP and METH were equally effective in sustaining retention in treatment and compliance with medication at week 12 (61.5 versus 59.2). Retention rate was influenced by dose, psychosocial functioning and not by psychiatric comorbidity in METH patients. In contrast, BUP maintained patients who completed the observational period showed a significantly higher rate of depression than those who dropped out (P < 0.01) and the intention to treat sample (P < 0.05). No relationship between retention and dose, or retention and psychosocial functioning was evidenced for BUP patients. The risk of positive urine testing was similar between METH and BUP, as expression of illicit drug use in general. At week 12, the patients treated with METH showed more risk of illicit opioid use than those treated with BUP (32.1% versus 25.6%) (P < 0.05). Negative urines were associated with higher doses in both METH and BUP patients. As evidenced for retention, substance abuse history and psychosocial functioning appear unable to influence urinalyses results in BUP patients. Buprenorphine maintained patients who showed negative urines presented a significantly higher rate of depression than those with positive urines (P < 0.05). Alternatively, psychiatric comorbidity was found unrelated to urinalyses results in METH patients. Our data need to be interpreted with caution because of the observational clinical methodology and non-random procedure. The present findings provide further support for the utility of BUP in the treatment of opioid dependency and demonstrate efficacy equivalent to that of METH during a clinical procedure. BUP seems to be more effective than METH in patients affected by depressive traits and dysphoria, probably due to antagonist action on kappa-opioid receptors. Psychosocial functioning and addiction severity cannot be used as valuable predictors of BUP treatment outcome. High doses appear to predict a better outcome, in term of negative urines, for both METH and BUP, but not in term of retention for BUP patients.

In the present study is described an immunoenzymatic assay for a new semi-synthetic immunomodulator consisting of a fraction derived from the strain ATCC 53966 of Corynebacterium granulosum to which were coupled polyaminoacid chains as a carrier to improve the oral bioavailability of the compound. This assay consists of having the specific antibody reacting with the compound and to determine the amount of antibody that has bound to the compound. For this the bound antibody was first reacted with the corresponding antispecies IgG antibody labelled with an enzyme and then the immobilized labelled antibody was revealed by a colorimetric reaction using a chromogenic substrate. The assay has further been validated by calculating the correlation factor linking the results obtained using the immuno-enzymatic assay to those obtained by determining with the aid of gas chromatography the concentration of muramic acid, a component characteristic of the compound structure.

Objectives The aim of this work was to compare in vitro the aerodynamic behavior of an amikacin sulphate liquid solution after nebulization and an amikacin dry powder (AmikaPS) after aerosolization. AmikaPS, was prepared using a proprietary spray drying technology to construct a powder to inhale having high content of drug and respirability. Methods Amikacin solution for injection was nebulized with Pari Turbo boy equipped with a Pari LC plus cup. AmikaPS powder was loaded in the DPI device (RS01, Plastiape) at the labeled dose of 125 mg of amikacin sulfate. Results The dosage of amikacin solution given off-label by nebulization is 625 mg/twice a day. At the end of the nebulization, it was found that, more than 50% of the amikacin dose (625 mg amikacin sulfate corresponding to 500 mg amikacin base) remained in the ampule, about 20% was dispersed in the environment and only 17.6% of the loaded dose was delivered as aerosol available for inhalation. Thus, since the respirable fraction of this aerosol was 56.3%, the dose to lung after 625 mg nebulization resulted 61.8 mg of amikacin sulfate. The fine particle dose of AmikaPS powder was 63.8 mg of amikacin sulfate. The data indicate that 125 mg of amikacin sulfate powder afford a respirable dose equivalent, or even slightly higher than that obtained by nebulizing 3 mL of solution for injection containing 625 mg of amikacin sulfate. Conclusions The objective of the proposed amikacin product is to offer a valid alternative to the other antibiotics for inhalation, keeping as low as possible the amount of powder to be inhaled by the patient while maximizing the amount of active ingredient deposited in the lung.