Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India.

BACKGROUND: This study assessed safety and immunogenicity of Serum Institute of India Pvt Ltd (SIIPL)'s tetanus toxoid (TT), diphtheria toxoid (DT), and acellular pertussis booster vaccine (Tdap). RESEARCH DESIGN AND METHODS: In this Phase II/III, multicenter, randomized, active-controlled, open-label study, 1500 healthy individuals, aged 4-65 years, were randomized to receive a single dose of SIIPL Tdap or comparator Tdap vaccine (Boostrix®; GlaxoSmithKlines, India). Adverse events (AEs) during initial 30 minutes, 7-day, 30-day post-vaccination were assessed. Blood samples were taken before and 30 days post-vaccination for immunogenicity assessment. RESULTS: No significant differences in incidence of local and systemic solicited AEs were observed between the two groups; no vaccine-related serious AEs were reported. SIIPL Tdap was non-inferior to comparator Tdap in achieving booster responses to TT and DT in 75.2% and 70.8% of the participants, respectively, and to pertussis toxoid (PT), pertactin (PRN), and filamentous hemagglutinin (FHA) in 94.3%, 92.6%, and 95.0% of the participants, respectively. Anti-PT, anti-PRN, and anti-FHA antibody geometric mean titers in both the groups, were significantly higher post-vaccination compared to pre-vaccination. CONCLUSIONS: Booster vaccination with SIIPL Tdap was non-inferior to comparator Tdap with respect to immunogenicity against tetanus, diphtheria, and pertussis and was well tolerated.

Apert's syndrome: Study by whole exome sequencing.

In the present study we attempted a parent-child trio, whole exome sequencing (WES) approach to study Apert's syndrome. Clinical characteristics of the child were noted down and WES was carried out using Ion Torrent System that revealed the presence of previously reported P253R mutation in FGFR2 gene. Presence of two SNPs rs1047057 and rs554851880 in FGFR2 gene with an allelic frequency of 0.5113 and 0.001176 respectively and 161 complete damaging mutations were found. This study is the first reported case of exome sequencing approach on an Apert's syndrome patient aimed at providing better genetic counselling in a non-consanguineous relationship.

Surgical management of strabismus in Duane retraction syndrome.

SUMMARY: While Duane retraction syndrome (DRS) is relatively common, surgical management of the associated strabismus can be challenging because of the lack of abduction/adduction, the variable severity of muscle contracture, and the variety of clinical presentations. In this workshop a panel of experienced surgeons provide their perspective and practical tips on the management of strabismus in patients with DRS.

Formulation and evaluation of bi-layer floating tablets of ziprasidone HCl and trihexyphenidyl HCl / Formulação e avaliação de bi-camada comprimidos flutuantes de ziprasidona HCl e HCl triexifenidila

The purpose of this research study was to establish ziprasidone HCl NR 40 mg and trihexyphenidyl HCl SR 4mg in the form of bi-layer sustained release floating tablets. The tablets were prepared using sodium HPMC K4M / HPMC K15M as bio-adhesive polymers and sodium bicarbonate acting as a floating layer. Tablets were evaluated based on different parameters such as thickness, hardness, friability, weight variation, in vitro dissolution studies, content of active ingredient and IR studies. The physico-chemical properties of the finished product complied with the specifications. In vitro release from the formulation was studied as per the USP XXIII dissolution procedure. The formulations gave a normal release effect followed by sustained release for 12 h which indicates bimodal release of ziprasidone HCl from the matrix tablets. The data obtained was fitted to Peppas models. Analysis of n values of the Korsmeyer equation indicated that the drug release involved non-diffusional mechanisms. By the present study, it can be concluded that bi-layer tablets of ziprasidone HCl and trihexyphenidyl HCl will be a useful strategy for extending the metabolism and improving the bioavailability of Ziprasidone HCl and Trihexyphenidyl HCl.

O propósito deste trabalho foi preparar ziprasidona. HCl NR 40 mg e triexifenidila.HCl SR 4 mg na forma de comprimidos efervescentes bicamada de liberação controlada. Os comprimidos foram preparados utilizando HPMC K4M / HPMC K15M sódico como polímero bioadesivo e bicarbonato como camada efervescente. Os comprimidos foram avaliados quanto a diferentes parâmetros, como espessura, dureza, friabilidade, variação de peso, dissolução in vitro, conteúdo do ingrediente ativo e estudos de IV. As propriedades físico-químicas dos produtos finais cumprem as especificações. A liberação in vitro da formulação foi estudada de acordo com o procedimento de dissolução da USP XXIII. As formulações resultaram em liberação normal, seguida por liberação controlada por 12 h, o que indica a liberação bimodal de cloridrato de ziprasidona dos comprimidos matriz. Os dados obtidos se adequaram aos modelos de Peppas. A análise de valores de n da equação de Korsmeyer indicou que a liberação do fármaco envolveu mecanismos não difusionais. Por este estudo, pode-se concluir que os comprimidos bicamada de ziprasidona.HCl e de triexifenidila.HCl serão um bom caminho para estender o metabolismo e para melhorar a biodisponibilidade de ziprasidona.HCl e de triexifenidila.HCl.

Acquired brown syndrome secondary to superior oblique muscle cysticercosis.

BACKGROUND: Acquired Brown syndrome is known to occur after trauma, iatrogenic events, cysts of superior oblique muscle tendon, and inflammation. The purpose of this study is to report a large series of patients with acquired Brown syndrome secondary to superior oblique muscle cysticercosis and to discuss its management. METHODS: Retrospective analysis was performed of clinical and imaging features, management, and outcome in seven patients with cysticercosis of the superior oblique muscle presenting clinically as Brown syndrome. RESULTS: Seven patients were identified (five male and two female) ranging in age from 6 to 45 years. All patients had the ocular motility limitation, ie, limitation of elevation in adduction., characteristic of Brown syndrome. This was associated with pain and swelling in the superior nasal orbit. Diagnosis was established by observing the cysticercus cyst with scolex on imaging (ultrasound B scan, magnetic resonance imaging, and/or computed tomography). Oral albendazole (15 mg/kg) and oral prednisolone (1mg/kg) were given for 4 weeks, and the patients were followed up for 1 year. Clinical recovery with improvement of ocular motility and regression of imaging features was noted in all patients. CONCLUSIONS: Acquired Brown syndrome secondary to superior oblique muscle cysticercosis is a rare entity. Awareness of this condition, which leads to early diagnosis and institution of prompt medical treatment, results in a successful clinical outcome.

Treatment of upshoot and downshoot in Duane syndrome by recession and Y-splitting of the lateral rectus muscle.

BACKGROUND: Duane syndrome is characterized by abduction deficiency, narrowing of the palpebral fissure with retraction of globe on attempted adduction, and upshoot or downshoot, which can be the most prominent feature of the motility disorder. The upshoot and downshoot is believed to be caused by a tautness or leash effect from the lateral rectus muscle. The purpose of this study was to present the results of recession of the lateral rectus muscle with Y-splitting in the treatment of upshoot and downshoot in Duane syndrome. METHODS: Ten patients with Duane syndrome underwent surgery for severe upshoot or downshoot. Lateral rectus muscles recession from 5.0 to 9.0 mm and Y-splitting was accomplished in all patients. In 6 patients, the medial rectus muscles were recessed simultaneously from 5.0 to 6.0 mm to correct the associated marked globe retraction and ocular deviation. RESULTS: Mean age at the time of surgery was 9.9 +/- 6.9 years (range, 3 to 20). Median follow up was 6 months (range, 3 weeks to 3 years). After surgery, all patients showed a marked decrease in upshoot or downshoot as well as improvement in globe retraction and face turn, where present. CONCLUSIONS: Recession of lateral rectus muscle with Y-splitting is an extremely effective procedure in the treatment of significant upshoot and downshoot associated with globe retraction in Duane syndrome. When combined with simultaneous recession of the medial rectus muscle, it improves globe retraction and corrects ocular deviation.