Review on the Scale-Up Methods for the Preparation of Solid Lipid Nanoparticles.

Solid lipid nanoparticles (SLNs) are an alternate carrier system to liposomes, polymeric nanoparticles, and inorganic carriers. SLNs have attracted increasing attention in recent years for delivering drugs, nucleic acids, proteins, peptides, nutraceuticals, and cosmetics. These nanocarriers have attracted industrial attention due to their ease of preparation, physicochemical stability, and scalability. These characteristics make SLNs attractive for manufacture on a large scale. Currently, several products with SLNs are in clinical trials, and there is a high possibility that SLN carriers will quickly increase their presence in the market. A large-scale manufacturing unit is required for commercial applications to prepare enough formulations for clinical studies. Furthermore, continuous processing is becoming more popular in the pharmaceutical sector to reduce product batch-to-batch differences. This review paper discusses some conventional methods and the rationale for large-scale production. It further covers recent progress in scale-up methods for the synthesis of SLNs, including high-pressure homogenization (HPH), hot melt extrusion coupled with HPH, microchannels, nanoprecipitation using static mixers, and microemulsion-based methods. These scale-up technologies enable the possibility of commercialization of SLNs. Furthermore, ongoing studies indicate that these technologies will eventually reach the pharmaceutical market.

Pilot Study for the Fidelity, Acceptability and Effectiveness of a PBIS Program plus Mental Health Supports in Under-resourced Urban Schools.

This paper describes implementation (fidelity, perceived acceptability) and tier 1 and tier 2 outcomes of a school-wide positive behavior interventions and supports approach (PBIS) including mental health supports at tier 2 in two K-8 urban schools. Interventions for tier 2 consisted of three manualized group cognitive behavioral therapy (GCBT) protocols for externalizing behavior problems, depression and anxiety. tier 1 and tier 2 interventions were implemented with fidelity but program feasibility for tier 2 was in question because school personnel needed a great deal of external support in order to implement the interventions. tier 1 interventions were associated with a decrease in office discipline referrals. Students participating in GCBT showed a significant decrease in mental health diagnostic severity at post-treatment. A discussion of perceived and actual implementation barriers and how they were addressed is provided. Implications for practice in low-income urban schools are discussed.

Group CBT for Externalizing Disorders in Urban Schools: Effect of Training Strategy on Treatment Fidelity and Child Outcomes.

Public schools are an ideal setting for the delivery of mental health services to children. Unfortunately, services provided in schools, and more so in urban schools, have been found to lead to little or no significant clinical improvements. Studies with urban school children seldom report on the effects of clinician training on treatment fidelity and child outcomes. This study examines the differential effects of two levels of school-based counselor training: training workshop with basic consultation (C) vs. training workshop plus enhanced consultation (C+) on treatment fidelity and child outcomes. Fourteen school staff members (counselors) were randomly assigned to C or C+. Counselors implemented a group cognitive behavioral therapy protocol (Coping Power Program, CPP) for children with or at risk for externalizing behavior disorders. Independent coders coded each CPP session for content and process fidelity. Changes in outcomes from pre to post were assessed via a parent psychiatric interview and interviewer-rated severity of illness and global impairment. Counselors in C+ delivered CPP with significantly higher levels of content and process fidelity compared to counselors in C. Both C and C+ resulted in significant improvement in interviewer-rated impairment; the conditions did not differ from each other with regard to impairment. Groups did not differ with regard to pre- to- posttreatment changes in diagnostic severity level. School-based behavioral health staff in urban schools are able to implement interventions with fidelity and clinical effectiveness when provided with ongoing consultation. Enhanced consultation resulted in higher fidelity. Enhanced consultation did not result in better student outcomes compared to basic consultation. Implications for resource allocation decisions with staff training in EBP are discussed.

Distance-Learning, ADHD Quality Improvement in Primary Care: A Cluster-Randomized Trial.

OBJECTIVE: To evaluate a distance-learning, quality improvement intervention to improve pediatric primary care provider use of attention-deficit/hyperactivity disorder (ADHD) rating scales. METHODS: Primary care practices were cluster randomized to a 3-part distance-learning, quality improvement intervention (web-based education, collaborative consultation with ADHD experts, and performance feedback reports/calls), qualifying for Maintenance of Certification (MOC) Part IV credit, or wait-list control. We compared changes relative to a baseline period in rating scale use by study arm using logistic regression clustered by practice (primary analysis) and examined effect modification by level of clinician participation. An electronic health record-linked system for gathering ADHD rating scales from parents and teachers was implemented before the intervention period at all sites. Rating scale use was ascertained by manual chart review. RESULTS: One hundred five clinicians at 19 sites participated. Differences between arms were not significant. From the baseline to intervention period and after implementation of the electronic system, clinicians in both study arms were significantly more likely to administer and receive parent and teacher rating scales. Among intervention clinicians, those who participated in at least 1 feedback call or qualified for MOC credit were more likely to give parents rating scales with differences of 14.2 (95% confidence interval [CI], 0.6-27.7) and 18.8 (95% CI, 1.9-35.7) percentage points, respectively. CONCLUSION: A 3-part clinician-focused distance-learning, quality improvement intervention did not improve rating scale use. Complementary strategies that support workflows and more fully engage clinicians may be needed to bolster care. Electronic systems that gather rating scales may help achieve this goal. Index terms: ADHD, primary care, quality improvement, clinical decision support.