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Kramtomųjų paracetamolio tablečių vaikams technologija / Chewable Paracetamol tablets for children technologyElijošius, Evaldas 28 June 2011 (has links)
Šiuo metu Lietuvoje pramoniniu būdu gaminamų farmacinių formų vaikams kiekis yra ribotas (2009/2010m. Lietuvos Respublikos Vaistinių preparatų registro duomenimis). Atlikus eilę studijų, buvo nutarta sukurti kramtomųjų paracetamolio tablečių vaikams gamybos technologiją. Surinkome ir susisteminome duomenis apie galimus technologinius tablečių gamybos variantus. Ištyrėme paracetamolio ir pasirinktų pagalbinių medžiagų technologines savybes. Išanalizavome mokslinius duomenis apie granuliacijos metodus bei technologinius tabletavimo būdus. Nustatytos reikiamos miltelių technologinės savybės, parinktos pagalbinės medžiagos ir jų kiekiai, leidžiantys pagaminti tabletes naudojant drėgnąjį miltelių granuliavimą. Tabletės presuotos ekscentrine tabletavimo mašina „Diaf“. Pagamintos 330 mg vidutinės masės tabletės; jos taisyklingos formos, lygiais kraštais, turi švelnų vienalytį paviršių, 9 mm diametro, 3 mm aukščio. Ištyrėme tablečių kokybei keliamus Europos Farmakopėjos reikalavimus: tablečių tvirtumą nusitrynimui, tvirtumą spaudimui, vidutinę tablečių masę, tablečių suirimą ir tirpimą. Įvertintas pagamintų tablečių stabilumas laikant. Atlikti tyrimai parodė, kad panaudota technologija įgalina pagaminti kramtomąsias paracetamolio tabletes vaikams, kurios atitinka Europos Farmakopėjos tabletėms keliamus reikalavimus. / On this time in Lithuania we don‘t have enough medicinal drug forms for children, which are made by industrial methods (we collated all registred drug forms for children, which are in Lithuania‘s drugs registration list). After long science studies, we decided to create the chewabe tablets for children manufacturing technology. First of all we collected information about all possible tablets manufacturing technology variants, collected information about paracetamol and supplementary materials. We have learned about granulation methods and tablet manufacturing variants. Was established powder tachnological characteristics. Selected supplementary materials and it‘s count, that would let us to create tablets by wet granuliating. Tablets was pressed by eccentric tablet machine „Diaf“. Was made 330 mg average mass, regular form, with flat edges tablets. Its have soft smooth surface, 9 mm diameter, 3 mm height. Data set about tablets quality by European Pharmacopoeia requirements: tablets strength for abrasion, strength for pressure, average tablets mass, tablets disintegration and tablets dissolution. We accomplished tablets stability tests. Accomplished studies have shown, that we could make chewable paracetamol tablets for children by selected technology. Those tablets passes through all European Pharmacopoeia requirements.
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Desenvolvimento e avaliação de formas farmacêuticas sólidas contendo didanosina / Development and evaluation of solid dosage forms containing didanosineAndreo Filho, Newton 16 November 2006 (has links)
A Síndrome da Imunodeficiência Adquirida (AIDS) é uma doença de amplo espectro de manifestações, sendo razão de preocupação para qualquer autoridade sanitária. A terapêutica da AIDS é complexa sendo utilizados vários medicamentos, diversas vezes ao dia. Deste modo, objetivou-se o desenvolvimento de formas farmacêuticas sólidas como comprimidos tamponados mastigáveis (CTM), comprimidos com revestimento gastro-resistentes (CRGR) e pellets (PEL) para a veiculação de didanosina (ddl). Seis especialidades farmacêuticas na forma de CTM foram estudadas quanto ao perfil de dissolução, pH do meio e capacidade neutralizante ácida (CNA). Formulações teste de CTM foram propostas visando obter CNAs e perfis de dissolução adequados. Também foram testadas formulações de comprimidos e de pellets para posterior revestimento com filme gastro-resistente derivado do ácido metacrílico. Os ensaios de dissolução das amostras de CTM revelaram diferenças nas características de liberação do fármaco. Também foram observadas diferenças relacionadas a CNA. As formulações de CTM propostas apresentaram, na maioria dos casos, adequados perfis de dissolução e CNA. As formulações CRGR que receberam revestimento gastro-resistente apresentaram perfis de dissolução de ddl adequados, entretanto os comprimidos testados intumesceram em meio ácido, indicando descontinuidade do filme polimérico sobre os comprimidos. Testes para a produção de pellets veiculando ddl mostraram-se adequados quanto à morfologia e dissolução do fármaco, o mesmo sendo observado após o revestimento com filme gastro-resistente. / The Acquired Immune Deficiency Syndrome (AIDS) is a disease that manifests itself in a myriad of ways. Because of this, the condition has been subject of concern to all sanitary authorities. The treatment of AIDS is complex and many types of medicine are used, many times a day. The objective of the present study was to develop solid pharmaceutical dosage forms such as buffered chewable tablets (CTM), gastro-resistant coating tablets (CRGR) and pellets (PEL) for the loading of didanosine (ddl). Six pharmaceutical specialties in the form of CTM were studied so as to identify the profile of the dissolution, the pH of the environment, and the neutralizing acid capacity (CNA). The use of CTM tests formulations was proposed with the objective of obtaining adequate CNA and dissolution profiles. Different compositions of tablets and pellets were tested for a later addition of gastro-resistant film derived from the methacrylic acid. The experiments on the dissolution of the sample of CTM showed differences in the characteristic of the release of the substance. Differences related to the CNA were also observed. The formulations of the CTM proposed showed to have, in the most number of the cases, both adequate dissolution behavior and CNA. The formulations of the CRGR that had received the gastro-resistant coating showed adequate profile of ddl dissolution; the tested tablets, however, swelled in the acid environment, therefore indicating a lack of continuity of the polymeric film over the tablets. The tests for the production of pellets showed adequate results as to its morphology and dissolution of ddl. The same was observed after coating the pellets with gastro-resistant film.
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Desenvolvimento e avaliação de formas farmacêuticas sólidas contendo didanosina / Development and evaluation of solid dosage forms containing didanosineNewton Andreo Filho 16 November 2006 (has links)
A Síndrome da Imunodeficiência Adquirida (AIDS) é uma doença de amplo espectro de manifestações, sendo razão de preocupação para qualquer autoridade sanitária. A terapêutica da AIDS é complexa sendo utilizados vários medicamentos, diversas vezes ao dia. Deste modo, objetivou-se o desenvolvimento de formas farmacêuticas sólidas como comprimidos tamponados mastigáveis (CTM), comprimidos com revestimento gastro-resistentes (CRGR) e pellets (PEL) para a veiculação de didanosina (ddl). Seis especialidades farmacêuticas na forma de CTM foram estudadas quanto ao perfil de dissolução, pH do meio e capacidade neutralizante ácida (CNA). Formulações teste de CTM foram propostas visando obter CNAs e perfis de dissolução adequados. Também foram testadas formulações de comprimidos e de pellets para posterior revestimento com filme gastro-resistente derivado do ácido metacrílico. Os ensaios de dissolução das amostras de CTM revelaram diferenças nas características de liberação do fármaco. Também foram observadas diferenças relacionadas a CNA. As formulações de CTM propostas apresentaram, na maioria dos casos, adequados perfis de dissolução e CNA. As formulações CRGR que receberam revestimento gastro-resistente apresentaram perfis de dissolução de ddl adequados, entretanto os comprimidos testados intumesceram em meio ácido, indicando descontinuidade do filme polimérico sobre os comprimidos. Testes para a produção de pellets veiculando ddl mostraram-se adequados quanto à morfologia e dissolução do fármaco, o mesmo sendo observado após o revestimento com filme gastro-resistente. / The Acquired Immune Deficiency Syndrome (AIDS) is a disease that manifests itself in a myriad of ways. Because of this, the condition has been subject of concern to all sanitary authorities. The treatment of AIDS is complex and many types of medicine are used, many times a day. The objective of the present study was to develop solid pharmaceutical dosage forms such as buffered chewable tablets (CTM), gastro-resistant coating tablets (CRGR) and pellets (PEL) for the loading of didanosine (ddl). Six pharmaceutical specialties in the form of CTM were studied so as to identify the profile of the dissolution, the pH of the environment, and the neutralizing acid capacity (CNA). The use of CTM tests formulations was proposed with the objective of obtaining adequate CNA and dissolution profiles. Different compositions of tablets and pellets were tested for a later addition of gastro-resistant film derived from the methacrylic acid. The experiments on the dissolution of the sample of CTM showed differences in the characteristic of the release of the substance. Differences related to the CNA were also observed. The formulations of the CTM proposed showed to have, in the most number of the cases, both adequate dissolution behavior and CNA. The formulations of the CRGR that had received the gastro-resistant coating showed adequate profile of ddl dissolution; the tested tablets, however, swelled in the acid environment, therefore indicating a lack of continuity of the polymeric film over the tablets. The tests for the production of pellets showed adequate results as to its morphology and dissolution of ddl. The same was observed after coating the pellets with gastro-resistant film.
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