The majority of therapeutic pharmaceutical formulations are presented in the solid form. Moisture is able to play an important role in the functional performance of pharmaceutical solids. Moisture profiling is able to provide novel information with regards to the behaviour of moisture within materials using equilibrium relative humidity as a measurement. The hypothesis investigated explores the changes in equilibrium relative humidity of pharmaceutical material induced by physical, chemical or storage conditions, these are able to be monitored using the innovative moisture profiler system. The aims within this were to primarily validate the moisture profiler and secondly evaluate the effects of moisture on physical forms and with respect to effects of compaction, finally this was compared to conventional characterisation methods. Preliminary explorations were conducted in order to assess the validity of the moisture profiler, from this lactose was selected as a suitable pharmaceutical material for further work. Processing effects were then examined, firstly storage at elevated relative humidity of different forms of lactose were explored, and this was carried out with supplementary analysis. Secondly the effects of tabletting were explored, different compaction forces were investigated to observe if this had any notable effects on equilibrium relative humidity of the different lactose forms. Finally subsequent storage of the compacts were examined in order to explore if there were any changes in the equilibrium relative humidity. / EPSRC and Reckitt Benckiser

The majority of therapeutic pharmaceutical formulations are presented in the solid form. Moisture is able to play an important role in the functional performance of pharmaceutical solids. Moisture profiling is able to provide novel information with regards to the behaviour of moisture within materials using equilibrium relative humidity as a measurement. The hypothesis investigated explores the changes in equilibrium relative humidity of pharmaceutical material induced by physical, chemical or storage conditions, these are able to be monitored using the innovative moisture profiler system. The aims within this were to primarily validate the moisture profiler and secondly evaluate the effects of moisture on physical forms and with respect to effects of compaction, finally this was compared to conventional characterisation methods. Preliminary explorations were conducted in order to assess the validity of the moisture profiler, from this lactose was selected as a suitable pharmaceutical material for further work. Processing effects were then examined, firstly storage at elevated relative humidity of different forms of lactose were explored, and this was carried out with supplementary analysis. Secondly the effects of tabletting were explored, different compaction forces were investigated to observe if this had any notable effects on equilibrium relative humidity of the different lactose forms. Finally subsequent storage of the compacts were examined in order to explore if there were any changes in the equilibrium relative humidity.

O federalismo conhece, na experiência moderna, diversas formações e conformações, segundo a ideologia que o permeia e a necessidade histórica que o explica e que o implica. Embora não seja possível falar em um modelo puro ou autêntico de federalismo, há uma característica que lhe é essencial, cuja falta negaria sua própria razão de ser: a coexistência, sob o mesmo poder soberano, de duas ou mais sociedades políticas dotadas de estatalidade. A estatalidade é informada pela existência de um poder político de inaugurar determinada ordem jurídica. No Estado dito unitário, trata-se da soberania. No Estado dito federativo, a soberania convive com o poder político dos Estados federados - a autonomia federativa. Assim como a soberania, a autonomia federativa é um poder político constituinte, mas, ao contrário daquela, é também poder político constituído (competência), limitado pelo poder soberano. A autonomia federativa implica, ainda, a competência para constituir competências políticas e governamentais. Tais limites são postos pelo poder soberano na Constituição do Estado federativo, que define o grau de autonomia federativa. Esse poder tem sofrido oscilações ao longo das Constituições republicanas brasileiras, havendo, em todas elas, considerável disparidade entre a autonomia federativa formal (que o texto revela) e a autonomia federativa real (que se pratica), causada, sobretudo, pelo antagonismo dos interesses políticos e econômicos que determinam, em última instância, a descentralização político-governamental. A presente tese propõe a conceituação e a delimitação da autonomia federativa formal no Direito Constitucional brasileiro posto pela Constituição da República Federativa do Brasil de 1988 / Federalism has had, in the modern experience, different frames and meanings, according to the ideology embedded into it and the historical necessity that explains and implies it. Although it is not possible to advocate a pure or authentic model for federalism, there is an essential feature, whose absence would deny its own reason for being: the coexistence, under the same sovereign power, of two or more political societies with statehood. Statehood is constituted by a political power capable to create a particular legal order. In so-called unitary states, such political power is the sovereignty. In federal states, the sovereignty of nation-state coexists with the political power of federated states - the federative autonomy. Like sovereignty, federative autonomy is a constitutional-political power. However, in contrast to the former, federative autonomy is also constituted political power (competence), limited by the sovereign power. The federative autonomy also implies the competence to establish political and governmental powers. These limits are set by the sovereign power in the Constitution of the federal state, which defines the degree of federative autonomy. Such power has oscillated along the Brazilian republican constitutions. All of them revealed considerable disparity between the formal federative autonomy (which the legal text provides) and the real federative autonomy (which is practiced), which was caused, mainly, by the antagonism between political and economic interests. Such interests ultimately determine political and governmental decentralization. This dissertation advocates the conceptualization and delimitation of formal federative autonomy in the Brazilian Constitutional Law set forth by the Constitution of the Federative Republic of Brazil.

O federalismo conhece, na experiência moderna, diversas formações e conformações, segundo a ideologia que o permeia e a necessidade histórica que o explica e que o implica. Embora não seja possível falar em um modelo puro ou autêntico de federalismo, há uma característica que lhe é essencial, cuja falta negaria sua própria razão de ser: a coexistência, sob o mesmo poder soberano, de duas ou mais sociedades políticas dotadas de estatalidade. A estatalidade é informada pela existência de um poder político de inaugurar determinada ordem jurídica. No Estado dito unitário, trata-se da soberania. No Estado dito federativo, a soberania convive com o poder político dos Estados federados - a autonomia federativa. Assim como a soberania, a autonomia federativa é um poder político constituinte, mas, ao contrário daquela, é também poder político constituído (competência), limitado pelo poder soberano. A autonomia federativa implica, ainda, a competência para constituir competências políticas e governamentais. Tais limites são postos pelo poder soberano na Constituição do Estado federativo, que define o grau de autonomia federativa. Esse poder tem sofrido oscilações ao longo das Constituições republicanas brasileiras, havendo, em todas elas, considerável disparidade entre a autonomia federativa formal (que o texto revela) e a autonomia federativa real (que se pratica), causada, sobretudo, pelo antagonismo dos interesses políticos e econômicos que determinam, em última instância, a descentralização político-governamental. A presente tese propõe a conceituação e a delimitação da autonomia federativa formal no Direito Constitucional brasileiro posto pela Constituição da República Federativa do Brasil de 1988 / Federalism has had, in the modern experience, different frames and meanings, according to the ideology embedded into it and the historical necessity that explains and implies it. Although it is not possible to advocate a pure or authentic model for federalism, there is an essential feature, whose absence would deny its own reason for being: the coexistence, under the same sovereign power, of two or more political societies with statehood. Statehood is constituted by a political power capable to create a particular legal order. In so-called unitary states, such political power is the sovereignty. In federal states, the sovereignty of nation-state coexists with the political power of federated states - the federative autonomy. Like sovereignty, federative autonomy is a constitutional-political power. However, in contrast to the former, federative autonomy is also constituted political power (competence), limited by the sovereign power. The federative autonomy also implies the competence to establish political and governmental powers. These limits are set by the sovereign power in the Constitution of the federal state, which defines the degree of federative autonomy. Such power has oscillated along the Brazilian republican constitutions. All of them revealed considerable disparity between the formal federative autonomy (which the legal text provides) and the real federative autonomy (which is practiced), which was caused, mainly, by the antagonism between political and economic interests. Such interests ultimately determine political and governmental decentralization. This dissertation advocates the conceptualization and delimitation of formal federative autonomy in the Brazilian Constitutional Law set forth by the Constitution of the Federative Republic of Brazil.