RESUMEN
As a result of the research activities of the Japan Agency for Medical Research and Development (AMED), this document aims to show an approach to establishing control strategy for continuous manufacturing of oral solid dosage forms. The methods of drug development, technology transfer, process control, and quality control used in the current commercial batch manufacturing would be effective also in continuous manufacturing, while there are differences in the process development using continuous manufacturing and batch manufacturing. This document introduces an example of the way of thinking for establishing a control strategy for continuous manufacturing processes.
Asunto(s)
Formas de Dosificación , Composición de Medicamentos/métodos , Administración Oral , Formas de Dosificación/normas , Composición de Medicamentos/normas , Industria Manufacturera/normas , Control de CalidadRESUMEN
Projectin is a giant protein related to twitchin and titin/connectin, that is found in arthropod striated muscle. The complete sequence of a 1 MDa projectin from Drosophila muscle was recently deduced from a thorough analysis of the genomic DNA (Southgate and Ayme-Southgate, 2001). Here we report the complete sequence for projectin from crayfish claw closer muscle (8625 residues; 962,634 Da). The N-terminal sequence contains 12 unique 19-residue repeats rich in glutamic acid (E) and lysine (K). This region, termed the EK region, is clearly distinguishable from the PEVK-like domain of Drosophila projectin. The sequence of crayfish flexor projectin differs from that of closer muscle projectin in that there is a 114-residue deletion and a 35-residue insertion in the N-terminal region. Immunofluorescence microscopy demonstrated that projectin is mainly localized within the sarcomeric A band in both closer and flexor muscles, although the N-terminal region was shown to extrude into the I band region. In the closer muscles, invertebrate connectin (D-titin) connects the Z line to the edge of the A band (Fukuzawa et al., 2001). We have shown that invertebrate connectin is also present in flexor muscle sarcomeres, although in very low abundance.
Asunto(s)
Astacoidea/genética , Proteínas Musculares/genética , Músculos/metabolismo , Sarcómeros/metabolismo , Secuencias de Aminoácidos/genética , Secuencia de Aminoácidos , Animales , Astacoidea/metabolismo , Proteínas de Caenorhabditis elegans , Proteínas de Unión a Calmodulina/metabolismo , ADN Complementario/genética , Ácido Glutámico/metabolismo , Lisina/metabolismo , Datos de Secuencia Molecular , Proteínas Musculares/metabolismo , Isoformas de Proteínas/genética , Isoformas de Proteínas/metabolismo , Sarcómeros/genéticaRESUMEN
Projectin is a giant filamentous protein of arthropod striated muscle. By using immunofluorescence microscopy, projectin was shown to span between the I band and the A band in locust (Locusta migratoria) flight muscle sarcomeres. The N- and C-terminal regions of projectin molecules were localized in the I band and A band, respectively. This observation explains the controversial reports of previous studies that projectin is localized either in the I band or in the A band of locust flight muscle sarcomeres. It is also observed that the N-terminal region of projectin is located in the I band of locust leg muscle sarcomeres.