Stability and compatibility study on enalapril maleate using thermoanalytical techniques

This paper demonstrates the application of thermal analysis in compatibility and stability studies between it ACE inhibitor (enalapril maleate) and excipients. The results have helped to elucidate the reason of a stability problem observed (luring the storage of enalapril maleate tablets. Incompatibility between enalapril maleate and colloidal silicon dioxide was detected. Besides, it was confirmed that the reaction between enalapril maleate and NaHCO3 increases the thermal stability of the drug. This Study Supports the importance of using thermoanalytical methods in the development of pharmaceuticals.

Thermal analysis and compatibility studies of prednicarbate with excipients used in semi solid pharmaceutical form

Differential Scanning Calorimetry (DSC), thermogravimetry/derivative thermogravimetry (TG/DTG) and infrared spectroscopy (IR) techniques were used to investigate the compatibility between prednicarbate and several excipients commonly used in semi solid pharmaceutical form. The thermoanalytical studies of 1:1 (m/m) drug/excipient physical mixtures showed that the beginning of the first thermal decomposition stage of the prednicarbate (T (onset) value) was decreased in the presence of stearyl alcohol and glyceryl stearate compared to the drug alone. For the binary mixture of drug/sodium pirrolidone carboxilate the first thermal decomposition stage was not changed, however the DTG peak temperature (T (peak DTG)) decreased. The comparison of the IR spectra of the drug, the physical mixtures and of the thermally treated samples confirmed the thermal decomposition of prednicarbate. By the comparison of the thermal profiles of 1:1 prednicarbate:excipients mixtures (methylparaben, propylparaben, carbomer 940, acrylate crosspolymer, lactic acid, light liquid paraffin, isopropyl palmitate, myristyl lactate and cetyl alcohol) no interaction was observed.

Compatibility and decomposition kinetics studies of prednicarbate alone and associated with glyceryl stearate

In this work, TG/DTG and DSC techniques were used to the determination of thermal behavior of prednicarbate alone and associated with glyceryl stearate excipient ( 1: 1 physical mixture). TG/DTG curves obtained for the binary mixture showed a reduction of approximately 37 degrees C to the thermal stability of drug (T(dm/dt-0) (Max)(DTG)). The disappearance of stretching band at 1280 cm(-1) (nu(as) C-O, carbonate group) and the presence of streching band with less intensity at 1750 cm(-1) (nu(s) C-O, ester group) in IR spectrum obtained to the binary mixture submitted at 220 degrees C, when compared with IR spectrum of drug submitted to the same temperature, confirmed the chemical interaction between these substances due to heating. Kinetics parameters of decomposition reaction of prednicarbate were obtained using isothermal (Arrhenius equation) and non-isothermal (Ozawa) methods. The reduction of approximately 45% of activation energy value (E(a)) to the first step of thermal decomposition reaction of drug in the 1:1 (mass/mass) physical mixture was observed by both kinetics methods.

Formulation development and evaluation of lamivudine controlled release tablets using cross-linked sago starch

Objectives: Modified starches based polymeric substances find utmost applicability in pharmaceutical formulation development. Cross-linked starches showed very promising results in drug delivery application. The present investigation concerns with the development of controlled release tablets of lamivudine using cross-linked sago starch. Methods: The cross-linked derivative was synthesized with phosphorous oxychloride and native sago starch in basic pH medium. The cross-linked sago starch was tested for acute toxicity and drug-excipient compatibility study. The formulated tablets were evaluated for various physical characteristics, in vitro dissolution release study and in vivo pharmacokinetic study in rabbit model. Results: In vitro release study showed that the optimized formulation exhibited highest correlation (R) in case of zero order kinetic model and the release mechanism followed a combination of diffusion and erosion process. There was a significant difference in the pharmacokinetic parameters (T-max, C-max, AUC, V-d, T-1/2, and MDT) of the optimized formulation as compared to the marketed conventional tablet Lamivir (R). Conclusion: The cross-linked starch showed promising results in terms of controlling the release behavior of the active drug from the matrix. The hydrophilic matrix synthesized by cross-linking could be used with a variety of active pharmaceutical ingredients for making their controlled/sustained release formulations.

Evaluation of microwave assisted grafted sago starch as controlled release polymeric carrier

In the present investigation an attempt has been made to develop a new co-polymeric material for controlled release tablet formulations. The acrylamide grafting was successfully performed on the backbone of sago starch. The modified starch was tested for acute toxicity and drug-excipient compatibility study. The grafted material was used in making of controlled release tablets of lamivudine. The formulations were evaluated for physical characteristics such as hardness, friability, %drug content and weight variations. The in vitro release study showed that the optimized formulation exhibited highest correlation (R) value in case of Higuchi model and the release mechanism of the optimized formulation predominantly exhibited combination of diffusion and erosion process. There was a significant difference in the pharmacokinetic parameters (T-max, C-max, AUC, V-d, T-1/2 and MDT) of the optimized formulation as compared to the marketed conventional tablet Lamivir (R) was observed. The pharmacokinetics parameters were showed controlled pattern and better bioavailability. The optimized formulation exhibited good stability and release profile at the accelerated stability conditions. (c) 2013 Elsevier B.V. All rights reserved.

Thermodynamical study on pressure-induced compatibility in UCST polymer-containing mixtures

The present calculations were performed on the basis of the Sanchez-Lacombe lattice fluid theory and the new combinatorial rules for block copolymer according to the experimental results on the pressure-induced compatibility in poly(ethylene oxide) (PEO) and poly(ethylene oxide-b-dimethylsiloxane) (P(EO-b-DMS)) mixtures with UCST behavior. The study on enthalpy, combinatorial entropy, vacancy entropy and Gibbs energy upon mixture shows that Sanchez-Lacombe fluid theory and the new combinatorial rules could describe the pressure-induced compatibility (PIC) of polymer mixtures with UCST behavior well.

Design for Manufacturing (DFM) – A case study of repetitive measures

Design for Manufacturing (DFM) is a highly integral methodology in product development, starting from the concept development phase, with the aim of improving manufacturing productivity and maintaining product quality. While Design for Assembly (DFA) is focusing on elimination or combination of parts with other components (Boothroyd, Dewhurst and Knight, 2002), which in most cases relates to performing a function and manufacture operation in a simpler way, DFM is following a more holistic approach. During DFM, the considerable background work required for the conceptual phase is compensated for by a shortening of later development phases. Current DFM projects normally apply an iterative step-by-step approach and eventually transfer to the developer team. Although DFM has been a well established methodology for about 30 years, a Fraunhofer IAO study from 2009 found that DFM was still one of the key challenges of the German Manufacturing Industry. A new, knowledge based approach to DFM, eliminating steps of DFM, was introduced in Paul and Al-Dirini (2009). The concept focuses on a concurrent engineering process between the manufacturing engineering and product development systems, while current product realization cycles depend on a rigorous back-and-forth examine-and-correct approach so as to ensure compatibility of any proposed design to the DFM rules and guidelines adopted by the company. The key to achieving reductions is to incorporate DFM considerations into the early stages of the design process. A case study for DFM application in an automotive powertrain engineering environment is presented. It is argued that a DFM database needs to be interfaced to the CAD/CAM software, which will restrict designers to the DFM criteria. Consequently, a notable reduction of development cycles can be achieved. The case study is following the hypothesis that current DFM methods do not improve product design in a manner claimed by the DFM method. The critical case was to identify DFA/DFM recommendations or program actions with repeated appearance in different sources. Repetitive DFM measures are identified, analyzed and it is shown how a modified DFM process can mitigate a non-fully integrated DFM approach.

Design for manufacturing : a review and case study

Design for Manufacturing (DFM) is a highly integral methodology in product development, starting from the concept development phase, with the aim of improving manufacturing productivity. It is used to reduce manufacturing costs in complex production environments, while maintaining product quality. While Design for Assembly (DFA) is focusing on elimination or combination of parts with other components, which in most cases relates to performing a function and manufacture operation in a simpler way, DFM is following a more holistic approach. Common consideration for DFM are standard components, manufacturing tool inventory and capability, materials compatibility with production process, part handling, logistics, tool wear and process optimization, quality control complexity or Poka-Yoke design. During DFM, the considerable background work required for the conceptual phase is compensated for by a shortening of later development phases. Current DFM projects normally apply an iterative step-by-step approach and eventually transfer to the developer team. The study is introducing a new, knowledge based approach to DFM, eliminating steps of DFM, and showing implications on the work process. Furthermore, a concurrent engineering process via transparent interface between the manufacturing engineering and product development systems is brought forward.

Re-strengthening 20th century architectural heritage : A case study of Brisbane City Hall restoration

Restoring old buildings to conform the current building policies and standards is a great challenge to engineers and architects. The restoration of the Brisbane City Hall, a heritage building listed by the State of Queensland in Australia, developed an innovative approach to upgrade the building using the method called ‘concrete overlay’ following the guidelines of both the International Council on Monuments and Sites and the Burra Charter of Australia. Concrete overlay is a new method of structural strengthening by drilling new reinforcement and placing new concrete on top of the existing structure, akin to a bone transplant or bone grafting in the case of a human being. This method is popularly used for newer bridges which have suffered load stresses. However, this method had never been used on any heritage buildings which were built on different conditions and standards. The compatibility of this method is currently being monitored. Most of the modern historic buildings are rapidly deteriorating and require immediate interventions in order to be saved. As most of these heritage buildings are on the stage of advanced deterioration, significant attempts are being made and several innovations are being applied to upgrade these structures to conform with the current building requirements. To date, the knowledge and literature in regarding ‘concrete cancer’ in relation to rehabilitating these reinforced concrete heritage structures is significantly lacking. It is hoped that the method of concrete overlay and the case study of Brisbane City Hall restoration will contribute to the development of restoration techniques and policies for Modern Heritage Buildings.

Awesome foursome? The compatibility of situation awareness across drivers, riders, cyclists, and pedestrians

Collisions between distinct road users (e.g. drivers and motorcyclists) make a substantial contribution to the road trauma burden. Although evidence suggests distinct road users interpret the same road situations differently, it is not clear how road users’ situation awareness differs, nor is it clear which differences might lead to conflicts. This article presents the findings from an on-road study which examined driver, cyclist, motorcyclist and pedestrian situation awareness at intersections. The findings suggest that situation awareness at intersection is markedly different across the four road user groups studied, and that some of these differences may create conflicts between the different road users. The findings also suggest that the causes of the differences identified relate to road design and road user experience. In closing, the key role of road design and training in supporting safe interactions between distinct road users is discussed.

Re-strengthening Brisbane City Hall : a case study of heritage engineering

Upgrading old buildings with the evolution of building requirements, this project investigates new approaches that can be applied to strengthen our own heritage buildings using historical and comparative analysis of heritage building restorations locally and abroad. Within the newly developing field of Heritage Engineering, it evaluates the innovative Concrete Overlay technique adapted to building restoration of the Brisbane City Hall. This study aims to extend the application of Concrete Overlay techniques and determine its compatibility specifically to heritage buildings. Concrete overlay involves drilling new reinforcement and placing concrete on top of the existing structure. It is akin to a bone transplant or bone grafting in the case of a human being and has been used by engineers to strengthen newer bridges.

Exploring schema-driven differences in situation awareness between road users : an on-road study of driver, cyclist and motorcyclist situation awareness

Collisions between different road users make a substantial contribution to road trauma. Although evidence suggests that different road users interpret the same road situations differently, it is not clear how road users' situation awareness differs, nor is it clear which differences might lead to conflicts. This article presents the findings from an on-road study conducted to examine driver, motorcyclist and cyclist situation awareness in different road environments. The findings suggest that, in addition to minor differences in the structure of different road users' situation awareness (i.e. amount of information and how it is integrated), the actual content of situation awareness in terms of road user schemata, the resulting interaction with the world and the information underpinning situation awareness is markedly different. Further examination indicates that the differences are likely to be compatible along arterial roads, shopping strips and at roundabouts, but that they may create conflicts between different road users at intersections. Interventions designed to support compatible situation awareness and behaviour between different road users are discussed. Practitioner Summary: Incompatible situation awareness plays a key role in collisions between different road users (e.g. drivers and motorcyclists). This on-road study examined situation awareness in drivers, motorcyclists and cyclists, identifying the key differences and potential conflicts that arise. The findings are used to propose interventions designed to enhance the compatibility of situation awareness between road users.

An exploratory study into director selection : who do directors want on their boards and how do they select them?

This exploratory study into director selection involved in-depth interviews with Australian non-executive directors to identify what directors consider as important criteria when selecting new members and the approach taken to identify and select candidates. The findings indicate boards select new members based not only on their ability to contribute complementary skills and experience but also on a perceived compatibility with incumbent board members. While these two selection criteria are considered equal in importance, not all selection approaches are able to adequately assess both criteria. As a result many selections fail to realise their selection criteria.

Compatibility of stormwater treatment performance data between different geographical areas

Using a case study approach, this paper presents a robust methodology for assessing the compatibility of stormwater treatment performance data between two geographical regions in relation to a treatment system. The desktop analysis compared data derived from a field study undertaken in Florida, USA, with South East Queensland (SEQ) rainfall and pollutant characteristics. The analysis was based on the hypothesis that when transposing treatment performance information from one geographical region to another, detailed assessment of specific rainfall and stormwater quality parameters is required. Accordingly, characteristics of measured rainfall events and stormwater quality in the Florida study were compared with typical characteristics for SEQ. Rainfall events monitored in the Florida study were found to be similar to events that occur in SEQ in terms of their primary characteristics of depth, duration and intensity. Similarities in total suspended solids (TSS) and total nitrogen (TN) concentration ranges for Florida and SEQ suggest that TSS and TN removal performances would not be very different if the treatment system is installed in SEQ. However, further investigations are needed to evaluate the treatment performance of total phosphorus (TP). The methodology presented also allows comparison of other water quality parameters.