Injection molding as a one-step process for the direct production of pharmaceutical dosage forms from primary powders.

The objective of the present study was to develop a one-step process for the production of tablets directly from primary powder by means of injection molding (IM), to create solid-dispersion based tablets. Fenofibrate was used as the model API, a polyvinyl caprolactame-polyvinyl acetate-polyethylene glycol graft co-polymer served as a matrix system. Formulations were injection-molded into tablets using state-of-the-art IM equipment. The resulting tablets were physico-chemically characterized and the drug release kinetics and mechanism were determined. Comparison tablets were produced, either directly from powder or from pre-processed pellets prepared via hot melt extrusion (HME). The content of the model drug in the formulations was 10% (w/w), 20% (w/w) and 30% (w/w), respectively. After 120min, both powder-based and pellet-based injection-molded tablets exhibited a drug release of 60% independent of the processing route. Content uniformity analysis demonstrated that the model drug was homogeneously distributed. Moreover, analysis of single dose uniformity also revealed geometric drug homogeneity between tablets of one shot.

Density of tobacco retailers and its association with sociodemographic characteristics of communities across New York.

OBJECTIVE: To examine the association of community median income, race/ethnicity and age with the availability of tobacco products in New York State and six subareas. STUDY DESIGN: Spatial regression analysis applied to licensed tobacco retailer and sociodemographic data in 2009 in New York. METHODS: This study assessed the association between tobacco retailer density and four demographic correlates (percentage African American, percentage Hispanic, percentage aged <18 years and median household income) at the census tract level in New York in 2009. Associations were modelled for New York State and six subareas: Greater New York City/Long Island, New York minus Greater New York City/Long Island (rest of State), the Capital region (containing the city of Albany and surrounding areas), Erie County (containing the city of Buffalo), Monroe County (containing the city of Rochester) and Onondaga County (containing the city of Syracuse). In total, 19,420 licensed tobacco retailers were linked to 4795 residential census tracts. RESULTS: In New York State, residential census tracts with higher proportions of African Americans and Hispanics generally had a significantly higher density of tobacco retailers. Census tracts with a higher percentage of residents aged <18 years and higher median household income generally had a significantly lower density of tobacco retailers. However, these associations were not statistically significant in all areas studied. CONCLUSIONS: Tobacco retailers tend to be more densely distributed in areas characterized by high minority or low-income populations, but these associations were not found in all areas. This may suggest that policy measures to reduce the density of tobacco retailers may be more effective at reducing disparities in tobacco availability and exposure to point-of-sale advertising in some areas than in others.

Anxiety in ethnic minority youth. Methodological and conceptual issues and review of the literature.

Although current research has documented a relatively high prevalence of anxiety disorders in American youth, this research has been conducted mainly with nonminority samples. Fair treatment and increasing numbers of ethnic minority persons in the United States require that more should be known about minority youth. However, research with majority youth cannot be safely generalized to minority youth for several reasons, such as potential differences in the manifestation of anxiety, differences in style of response to assessment devices, and different life circumstances. This review is presented in two major sections. First, the authors address definition of terms and fully examine the significance of studying anxiety in ethnic minority youth. Also considered are methodological issues such as sampling and participation biases. Second, the authors review anxiety in ethnic minority children and adolescents in the United States including studies addressing fears, worries, trait anxiety, test anxiety, and anxiety disorders.

Cognitive-behavioral group therapy versus phenelzine in social phobia: long-term outcome.

UNLABELLED: To evaluate the effects of maintenance treatment and durability of gains after treatment discontinuation, responders to either phenelzine (PZ) or cognitive-behavioral group therapy (CBGT) from an acute trial comparing these two treatments as well as pill placebo and a psychotherapy control (educational supportive group therapy) were enrolled into maintenance and treatment-free follow-up phases. EXPERIMENTAL DESIGN: Responders to an acute trial contrasting PZ and CBGT entered a six-month maintenance phase. Patients who continued to respond through the maintenance phase entered a six-month treatment free phase. Patients receiving pill placebo or educational supportive group therapy in the acute trial did not enter the long term study. PRINCIPAL OBSERVATIONS: PZ patients entered maintenance more improved than CBGT patients, and nonrelapsing PZ patients maintained their superior gains throughout the study. Relapse during maintenance did not differ between treatments. However, PZ patients showed a trend toward greater relapse during treatment-free follow-up. There was a greater relapse among patients with generalized social phobia with phenelzine. CONCLUSIONS: PZ and cognitive-behavioral group therapy may differ in their long term effects. The superiority seen with PZ on some measures in the acute study persisted in patients who maintained their gains over the course of maintenance and treatment-free follow-up. However, CBGT may lead to a greater likelihood of maintaining response after treatment has terminated. Replication with larger samples is needed, as is a study of the acute and long-term efficacy of combined PZ and CBGT.

Factor structure of social fears: The Liebowitz Social Anxiety Scale.

In the assessment of social anxiety, investigators often differentiate between social interactional anxiety and performance anxiety. The Liebowitz Social Anxiety Scale (LSAS), a clinician-administered measure of social anxiety and avoidance, was originally developed with separate subscales for the assessment of fear and avoidance of situations involving social interaction and performance/observation by others. Separate confirmatory factor analyses of the LSAS fear and avoidance ratings demonstrated that this two-factor model did not provide an adequate fit to the data, suggesting the need to further investigate the underlying structure of the LSAS. Separate exploratory common factor analyses of the fear and avoidance ratings yielded four similar factors for each: (1) social interaction, (2) public speaking, (3) observation by others, and (4) eating and drinking in public, which demonstrated convergent and discriminant validity with other measures of social anxiety. These findings suggest that there are four global categories of social fear assessed by the LSAS, and that while social interaction anxiety appears to be unifactorial, fear of performance/observation situations may be multifactorial.

Psychometric properties of the Liebowitz Social Anxiety Scale.

BACKGROUND: The present study provides data on the reliability, validity and treatment sensitivity of the Liebowitz Social Anxiety Scale (LSAS), one of the most commonly used clinician-administered scales for the assessment of social phobia. METHOD: Three hundred and eighty-two patients from several studies of the treatment of social phobia were evaluated. An independent assessor administered the LSAS to each patient prior to the initiation of treatment. Patients also completed other measures of social anxiety and avoidance, although the specific measures varied across samples. RESULTS: The LSAS and its subscales were normally distributed and demonstrated excellent internal consistency. The convergent validity of the LSAS was demonstrated via significant correlations with other commonly-used measures of social anxiety and avoidance. These correlations also tended to be larger than correlations with measures of depression, especially after treatment. However, the pattern of correlations of LSAS subscales with one another and with the other measures suggest that the fear subscales and the avoidance subscales may not be sufficiently distinct in clinical samples. The LSAS was also demonstrated to be sensitive to the effects of pharmacological treatments of social phobia over time and in comparison to double-blind pill placebo. CONCLUSION: The LSAS appears to be a reliable, valid and treatment sensitive measure of social phobia. Further study of the LSAS, both in samples with severe social phobia and in community samples, is needed.

Cognitive behavioral group therapy vs phenelzine therapy for social phobia: 12-week outcome.

BACKGROUND: This article presents results of the acute treatment phase of a 2-site study comparing cognitive behavioral group therapy (CBGT) and treatment with the monoamine oxidase inhibitor phenelzine sulfate for social phobia. METHODS: One hundred thirty-three patients from 2 sites received 12 weeks of CBGT, phenelzine therapy, pill placebo administration, or educational-supportive group therapy (an attention-placebo treatment of equal credibility to CBGT). The "allegiance effect," ie, the tendency for treatments to seem most efficacious in settings of similar theoretical orientation and less efficacious in theoretically divergent settings, was also examined by comparing responses to the treatment conditions at both sites: 1 known for pharmacological treatment of anxiety disorders and the other for cognitive behavioral treatment. RESULTS: After 12 weeks, phenelzine therapy and CBGT led to superior response rates and greater change on dimensional measures than did either control condition. However, response to phenelzine therapy was more evident after 6 weeks, and phenelzine therapy was also superior to CBGT after 12 weeks on some measures. There were few differences between sites, suggesting that these treatments can be efficacious at facilities with differing theoretical allegiances. CONCLUSIONS: After 12 weeks, both phenelzine therapy and CBGT were associated with marked positive response. Although phenelzine therapy was superior to CBGT on some measures, both were more efficacious than the control conditions. More extended cognitive behavioral treatment and the combination of modalities may enhance treatment effect.

Stressful life events and personality styles: relation to impairment and treatment outcome in patients with social phobia.

Forty-five patients with social phobia and 15 individuals with no mental disorder were compared on number and type of life events experienced. Social phobia patients were further examined to evaluate the effect of negative life events and of the interaction between personality style and life events on severity of impairment and reactions to cognitive-behavioral group therapy. Patients with social phobia reported more negative life events than participants with no mental disorder. Among patients with social phobia, more frequent negative life events were associated with higher scores on measures of depression and general anxiety. Patients high on autonomy who reported more negative autonomous (i.e., achievement-oriented) life events also scored higher on measures of social anxiety and general anxiety. There were no significant interactions between sociotropy and the frequency of reported socially oriented negative life events. However, patients high on sociotropy scored higher on measures of social anxiety, depression, and general anxiety. Patients who had experienced more negative life events improved more after treatment on measures of social anxiety than did those who had experienced fewer negative life events. Implications of these findings and recommendations for future research are discussed.

Clients' expectancies and their relationship to pretreatment symptomatology and outcome of cognitive-behavioral group treatment for social phobia.

The present study examined the expectancies of clients with social phobia that they would benefit from cognitive-behavioral group treatment. Lower expectancies for positive outcome were related to greater severity of social phobia, duration of social phobia, and depression. Lower expectancies were also reported by individuals with the generalized subtype of social phobia, but expectancies were not further influenced by the presence of other Axis I disorders. Expectancy ratings did not differ between clients who dropped out of treatment and those who did not, but, after pretreatment severity of social phobia was accounted for, expectancies significantly predicted improvement among treatment completers. Clients' expectancy beliefs may be an important factor to address in the prediction of who will benefit from a cognitive-behavioral treatment, even when that treatment has demonstrated specific efficacy.

Social phobia and PTSD in Vietnam veterans.

Posttraumatic stress disorder (PTSD) is the most prevalent psychological disorder experienced by Vietnam veterans. However, there are many other disorders and problems of adjustment, like social anxiety and social phobia, that have not been fully investigated in this population. This study examined the prevalence of social phobia and the comorbidity of social phobia and PTSD, and tested out a theory of the etiology of social anxiety in trauma victims. Forty one Vietnam combat veterans were interviewed and completed self-report measures assessing PTSD and social phobia. Adversity of homecoming was also assessed. Using a conservative multi-method assessment approach, 32% of the sample were found to be positive for both social phobia and PTSD. Veterans with PTSD were significantly more likely to carry an additional diagnosis of social phobia as compared to veterans without PTSD. Adversity of homecoming and shame about one's experience in Vietnam were significant predictors of current level of social anxiety over and above the effects of pre-military anxiety and severity of combat exposure. These observations suggest that social anxiety and social phobia may be significant problems among individuals with PTSD. Further, these findings offer preliminary support for the theory that posttrauma environment may impact upon the later development of social anxiety.

Social phobia. Longitudinal course and long-term outcome of cognitive-behavioral treatment.

Interest in social phobia has increased dramatically in the past decade, and our knowledge of this previously understudied disorder has increased as well. We now know that social phobia is a chronic condition and that patients with this disorder are unlikely to experience significant improvement without intervention. It is also a highly prevalent condition affecting as many as 13% of the adult population of the Unites States. Although our understanding of the causes of social phobia remains limited, we do know that it is associated with serious impairment and disability in multiple spheres. Thus, the development of treatments with proven long-term efficacy is an important research goal. In this article, we have reviewed studies that examined either exposure, cognitive restructuring, social skills training, or some combination of these treatments. Here, we summarize the major findings of this review. Exposure has fared well as a treatment for social phobia and, in every case, within-group analyses show that patients have improved after treatment. Methodologic problems in some studies, however, limit the conclusions that can be drawn about the comparative efficacy of exposure, social skills training, and relaxation therapy. Conceptual models of social phobia have stressed the importance of cognitive processes in the development and maintenance of social phobia and much attention has been directed at the long-term efficacy of cognitive-behavioral techniques. It has been hypothesized that exposure plus cognitive restructuring would be a particularly effective combination and several methodologically sound studies have examined this combination. These studies have demonstrated consistently clinically significant within-group changes and superiority to control conditions. Heimberg's CBGT is probably the most widely studied of these treatments. CBGT has been shown to be more effective than an equally credible attention-placebo group. Patients receiving CBGT have maintained their advantage over patients in the attention-placebo group, even 5 years after treatment although flaws in that follow-up study limit generalizability of its results. Generalized and nongeneralized social phobic patients respond equivalently to this highly integrated treatment, and it has been applied effectively by researchers outside the center where it was developed. Despite the successes of combined exposure and cognitive restructuring treatments, it remains unclear as to what the effective component(s) of these and similar treatments are and, therefore, whether or not the integration of therapy components is really necessary. A number of the studies reviewed addressed this question with mixed results. Three studies showed that the combination therapy was superior to either treatment alone. There is also evidence that patients treated with exposure only may show some deterioration during follow-up whereas patients treated with cognitive restructuring and exposure may continue to improve. Still, other studies found no differences in long-term outcome among exposure alone, RET, or the combined treatment. Hope et al found that exposure alone was as effective as an integrated treatment combining exposure and cognitive restructuring (CBGT), and Taylor and colleagues (submitted for publication, 1995) reported that exposure was not enhanced by initial treatment with cognitive restructuring. These results are disappointing in light of all that has been written about the likely benefits of combining cognitive and behavioral therapy in the treatment of social phobia. For example, it has been hypothesized that fear of negative evaluation is a key factor in social phobia and that change in this construct should be the goal of treatment. There is some research that supports this claim and other evidence that suggests that exposure alone is not particularly effective in producing those changes. Butler concluded that the treatment of social phobia is made more difficult whe

Self selection and sample selection in a treatment study of social phobia.

The external validity or generalizability of a treatment outcome study may be influenced by the choices patients make (self-selection) and by study requirements intended to increase internal validity or protect subject welfare (e.g. sample selection). Although these effects are well-known, they have rarely been studied, and little is known about the impact they may have on generalizability of findings. In this study, subjects accepting random assignment to a larger study examining pharmacologic and cognitive-behavioral treatments for social phobia were compared with subjects refusing random assignment (i.e. self-selected) and excluded subjects (i.e. "sample-selected"). "Acceptors" differed from "refusers" on some measures suggesting that they have a lower annual income and may have fewer social supports. Therefore, they may have fewer available resources and might be more willing to accept help wherever it is offered. Despite these differences, acceptors differed from refusers on just one pretreatment measure of clinical functioning. Excluded subjects did not differ from refusers or acceptors on demographic or pretreatment clinical measures. Refusers and excluded subjects were treated with the same cognitive-behavioral treatment used in the comparative outcome study, and their posttreatment data were compared with the subgroup of acceptors who were randomly assigned to that treatment. Again, there were few significant differences. These results suggest that while self-selection and sample selection may have influenced some characteristics of the sample in this comparative outcome study, the three groups of subjects were clinically similar and responded similarly to cognitive-behavioral treatment of social phobia.

Treatment of social phobia in cognitive-behavioral groups.

Interest in social phobia has increased dramatically since its inclusion in DSM-III, and several approaches to its treatment have been developed. In this paper, we focus on one specific treatment package known as Cognitive-Behavioral Group Treatment for Social Phobia (CBGT), which has been developed at the University at Albany's Center for Stress and Anxiety Disorders over the last several years. An overview of the techniques of CBGT is provided, and empirical studies that provide support for its effectiveness are reviewed. The paper is concluded with the detailed presentation of a patient who was treated with CBGT.

Insecticidal action of the phytohemagglutinin in black beans on a bruchid beetle.

Black bean (Phaseolus vulgaris) phytohemagglutinin added to the normal diet of a bruchid beetle (Callosobruchus maculatus) that can eat phytohemagglutinin-free cowpeas (Vigna unguiculata) but not P. vulgaris seeds kills the bruchid larvae. Trypsin inhibitors, found in both P. vulgaris and V. unguiculata seeds, have virtually no effect on the bruchid larvae. The conclusion is that a major part of the adaptive significance of phytohemagglutinins in black bean and other legume seeds is to protect them from attack by insect seed predators.