Supply chain management in the pharmaceutical industry

The Key to Further Enhancing Shareholder Value

Applied pharmaceutical practice

Applied Pharmaceutical Practice is an invaluable resource and will guide the student pharmacist and pharmacy technician through the main stages involved in pharmaceutical dispensing. As a core reference text, it is ideal as a companion to the compulsory dispensing courses found in all undergraduate MPharm programmes and the equivalent technical training courses. Contents include: •medicines classification and standard operating procedures •NHS supply in the community and within hospitals •non-NHS supply •controlled drugs •emergency supply •patient counselling and communication •poisons and spirits This practical textbook contains useful exercises with an answers section and numerous examples and is written by authors with extensive experience within the field. This is a comprehensive guide through the main stages of pharmaceutical dispensing.The textbook is designed to guide student pharmacists or pharmacy technicians through the main stages involved in pharmaceutical dispensing. It provides students with a core reference text to accompany the compulsory dispensing course found in all pharmacy undergraduate programmes, highlighting and explaining all key concepts behind the processes involved in pharmaceutical dispensing.

FASTtrack Applied Pharmaceutical Practice

This is a revision guide for students providing bullet points of basic information on dispensing. "The FASTtrack" series is a series of revision guides directly aimed at pharmacy students. Basic information will be provided on all main areas of study for the MPharm in small concise texts. Each title will provide a summary of all key information along with diagrams, cases and questions and answers for self assessment. The books will be practical, easy to read and well-priced and will complement textbooks and aid students with revision for examinations. This "FASTtrack" is a companion to the larger textbook "Applied Pharmaceutical Practice" (published September 2008) which was designed to guide the student pharmacist or pharmacy technician through the main stages involved in pharmaceutical dispensing. This title provides students with a core reference to accompany the compulsory dispensing courses found in all undergraduate pharmacy programmes. "FASTtrack: Applied Pharmaceutical Practice" is a condensed version with additional examples and questions. A "FASTtrack" website includes MCQs, sample online content and much more.

Pharmaceutical compounding and dispensing

This is a modern, detailed and practical guide to the theory and practice of extemporaneous compounding and dispensing. Fully revised and updated, this new edition will be an indispensable reference for pharmacy students and practicing pharmacists. Pharmacists have been responsible for compounding medicines for centuries. Although most modern medicines are not compounded in a local pharmacy environment, there are still occasions when it is imperative that pharmacists have this knowledge. Pharmaceutical Compounding and Dispensing provides a comprehensive guide to producing extemporaneous formulations safely and effectively.

FASTtrack applied pharmaceutical practice

This revision guide takes the student pharmacist or pharmacy technician through the main stages involved in pharmaceutical dispensing. It gives bullet points of basic information on applied pharmacy practice followed by questions and answers. This reference text accompanies the compulsory dispensing courses found in all undergraduate MPharm programmes and equivalent technical training courses. Changes for the new edition include: * Information on revisions to the community pharmacy contract. * Additional content on new advanced community pharmacy services. * Revised worked examples and student questions. * Updated prescription labelling information, including the use of new cautionary and warning labels. * Updated references and bibliography.

FASTtrack Pharmaceutical Compounding and Dispensing

FASTtrack: Pharmaceutical Compounding and Dispensing focuses on what you really need to know in order to pass exams. Concise, bulleted information, key points, tips and an all-important self-assessment section which includes MCQs, case studies, sample essay questions and worked examples. Based on the successful textbook, Pharmaceutical Compounding and Dispensing, this FASTtrack book has been designed to assist the student compounder in understanding the key dosage forms encountered within extemporaneous dispensing. For this new second edition all the references to modern texts (for example, the BNF) have been updated, as well as labelling to reflect changes since the publication of the first edition. Some worked examples have been changed owing to the availability of pharmaceutical ingredients. Free access to online videos demonstrating various dispensing procedures is included. Are your exams coming up? Are you drowning in textbooks and lecture notes and wondering where to begin? Take the FASTtrack route to successful study for your examinations. FASTtrack provides the ultimate lecture notes and is a must-have for all pharmacy students wanting to study and test themselves for forthcoming exams.

FASTtrack:pharmaceutical compounding and dispensing

This is a revision guide for students giving bullet points of basic information on pharmaceutical compounding and dispensing followed by questions and answers."Fast Track" is a new series of indispensable revision guides created especially for undergraduate pharmacy students.The content of each title focuses on what pharmacy students really need to know in order to pass exams, providing concise, bulleted information, key points, tips and an all-important self-assessment section which includes MCQs, case studies, sample essay questions and worked examples."The Fast Track" series provides the ultimate lecture notes and is a must-have for all pharmacy undergraduate students wanting to revise and test themselves for forthcoming exams.Based on the successful textbook, "Pharmaceutical Compounding and Dispensing", this book has been designed to assist the student compounder in understanding the key dosage forms encountered within extemporaneous dispensing.A Fast Track website will also be live at time of publication and will include MCQs, sample online content and much more.

Pharmaceutical process optimisation of bulk lyophilisates:implications of powder handling

Lyophilisation or freeze drying is the preferred dehydrating method for pharmaceuticals liable to thermal degradation. Most biologics are unstable in aqueous solution and may use freeze drying to prolong their shelf life. Lyophilisation is however expensive and has seen lots of work aimed at reducing cost. This thesis is motivated by the potential cost savings foreseen with the adoption of a cost efficient bulk drying approach for large and small molecules. Initial studies identified ideal formulations that adapted well to bulk drying and further powder handling requirements downstream in production. Low cost techniques were used to disrupt large dried cakes into powder while the effects of carrier agent concentration were investigated for powder flowability using standard pharmacopoeia methods. This revealed superiority of crystalline mannitol over amorphous sucrose matrices and established that the cohesive and very poor flow nature of freeze dried powders were potential barriers to success. Studies from powder characterisation showed increased powder densification was mainly responsible for significant improvements in flow behaviour and an initial bulking agent concentration of 10-15 %w/v was recommended. Further optimisation studies evaluated the effects of freezing rates and thermal treatment on powder flow behaviour. Slow cooling (0.2 °C/min) with a -25°C annealing hold (2hrs) provided adequate mechanical strength and densification at 0.5-1 M mannitol concentrations. Stable bulk powders require powder transfer into either final vials or intermediate storage closures. The targeted dosing of powder formulations using volumetric and gravimetric powder dispensing systems where evaluated using Immunoglobulin G (IgG), Lactate Dehydrogenase (LDH) and Beta Galactosidase models. Final protein content uniformity in dosed vials was assessed using activity and protein recovery assays to draw conclusions from deviations and pharmacopeia acceptance values. A correlation between very poor flowability (p<0.05), solute concentration, dosing time and accuracy was revealed. LDH and IgG lyophilised in 0.5 M and 1 M mannitol passed Pharmacopeia acceptance values criteria with 0.1-4 while formulations with micro collapse showed the best dose accuracy (0.32-0.4% deviation). Bulk mannitol content above 0.5 M provided no additional benefits to dosing accuracy or content uniformity of dosed units. This study identified considerations which included the type of protein, annealing, cake disruption process, physical form of the phases present, humidity control and recommended gravimetric transfer as optimal for dispensing powder. Dosing lyophilised powders from bulk was demonstrated as practical, time efficient, economical and met regulatory requirements in cases. Finally the use of a new non-destructive technique, X-ray microcomputer tomography (MCT), was explored for cake and particle characterisation. Studies demonstrated good correlation with traditional gas porosimetry (R2 = 0.93) and morphology studies using microscopy. Flow characterisation from sample sizes of less than 1 mL was demonstrated using three dimensional X-ray quantitative image analyses. A platinum-mannitol dispersion model used revealed a relationship between freezing rate, ice nucleation sites and variations in homogeneity within the top to bottom segments of a formulation.

Freezing process optimisation of pharmaceutical formulations for freeze drying

The body of work presented in this thesis are in three main parts: [1] the effect of ultrasound on freezing events of ionic systems, [2] the importance of formulation osmolality in freeze drying, and [3] a novel system for increasing primary freeze drying rate. Chapter 4 briefly presents the work on method optimisation, which is still very much in its infancy. Aspects of freezing such as nucleation and ice crystal growth are strongly related with ice crystal morphology; however, the ice nucleation process typically occurs in a random, non-deterministic and spontaneous manner. In view of this, ultrasound, an emerging application in pharmaceutical sciences, has been applied to aid in the acceleration of nucleation and shorten the freezing process. The research presented in this thesis aimed to study the effect of sonication on nucleation events in ionic solutions, and more importantly how sonication impacts on the freezing process. This work confirmed that nucleation does occur in a random manner. It also showed that ultrasonication aids acceleration of the ice nucleation process and increases the freezing rate of a solution. Cryopreservation of animal sperm is an important aspect of breeding in animal science especially for endangered species. In order for sperm cryopreservation to be successful, cryoprotectants as well as semen extenders are used. One of the factors allowing semen preservation media to be optimum is the osmolality of the semen extenders used. Although preservation of animal sperm has no relation with freeze drying of pharmaceuticals, it was used in this thesis to make a case for considering the osmolality of a formulation (prepared for freeze drying) as a factor for conferring protein protection against the stresses of freeze drying. The osmolalities of some common solutes (mostly sugars) used in freeze drying were determined (molal concentration from 0.1m to 1.2m). Preliminary investigation on the osmolality and osmotic coefficients of common solutes were carried out. It was observed that the osmotic coefficient trend for the sugars analysed could be grouped based on the types of sugar they are. The trends observed show the need for further studies to be carried out with osmolality and to determine how it may be of importance to protein or API protection during freeze drying processes. Primary drying is usually the longest part of the freeze drying process, and primary drying times lasting days or even weeks are not uncommon; however, longer primary drying times lead to longer freeze drying cycles, and consequently increased production costs. Much work has been done previously by others using different processes (such as annealing) in order to improve primary drying times; however, these do not come without drawbacks. A novel system involving the formation of a frozen vial system which results in the creation of a void between the formulation and the inside wall of a vial has been devised to increase the primary freeze drying rate of formulations without product damage. Although the work is not nearly complete, it has been shown that it is possible to improve and increase the primary drying rate of formulations without making any modifications to existing formulations, changing storage vials, or increasing the surface area of freeze dryer shelves.

EPCIS Event-Based traceability in pharmaceutical supply chains via automated generation of linked pedigrees

In this paper we show how event processing over semantically annotated streams of events can be exploited, for implementing tracing and tracking of products in supply chains through the automated generation of linked pedigrees. In our abstraction, events are encoded as spatially and temporally oriented named graphs, while linked pedigrees as RDF datasets are their specific compositions. We propose an algorithm that operates over streams of RDF annotated EPCIS events to generate linked pedigrees. We exemplify our approach using the pharmaceuticals supply chain and show how counterfeit detection is an implicit part of our pedigree generation. Our evaluation results show that for fast moving supply chains, smaller window sizes on event streams provide significantly higher efficiency in the generation of pedigrees as well as enable early counterfeit detection.

Functionalised particles using dry powder coating in pharmaceutical drug delivery:promises and challenges

Introduction: Production of functionalised particles using dry powder coating is a one-step, environmentally friendly process that paves the way for the development of particles with targeted properties and diverse functionalities. Areas covered: Applying the first principles in physical science for powders, fine guest particles can be homogeneously dispersed over the surface of larger host particles to develop functionalised particles. Multiple functionalities can be modified including: flowability, dispersibility, fluidisation, homogeneity, content uniformity and dissolution profile. The current publication seeks to understand the fundamental underpinning principles and science governing dry coating process, evaluate key technologies developed to produce functionalised particles along with outlining their advantages, limitations and applications and discusses in detail the resultant functionalities and their applications. Expert opinion: Dry particle coating is a promising solvent-free manufacturing technology to produce particles with targeted functionalities. Progress within this area requires the development of continuous processing devices that can overcome challenges encountered with current technologies such as heat generation and particle attrition. Growth within this field requires extensive research to further understand the impact of process design and material properties on resultant functionalities.

To what extent and in what manner do Chinese and Indian contract research organisation learn and upgrade with the unbundling the global pharmaceutical R&D value chain?

The paper applies the GVC framework to analyse the organisational and geographical reconfiguration of the global R&D function of leading US and European pharmaceutical MNCs. Though pharmaceutical MNCs have been outsourcing clinical trial activities since the mid-1990s, the outsourcing of discovery research tasks is a phenomenon of the 2000s (Ramirez 2013). Moreover, in the context of a crisis of R&D productivity and increasing pressure from shareholders, a number of US and European pharmaceutical MNCs are breaking up their R&D function in an attempt to increase flexibility and reduce risk as well as costs and are thereby restructuring the global architecture of their R&D function. This break-up, or unbundling (Sako 2006), of the R&D function is particularly interesting given the prevalence of market failure in innovation (Howells et al 2008), the non-modular nature of the R&D process in this industry (Pisano 2006) and the strategic important of this activity to the core competence and long-term competitive advantage of firms in this sector. The focus of this paper is on the outsourcing of R&D activities to Chinese and Indian independently-owned contract research organisations (CROs) and the way these firms are becoming integrated as service providers into the global R&D function (or R&D value chain) of pharmaceutical MNCs. Above all the paper is concerned with the development of capabilities of CROs from these two countries and the dynamics of upgrading in GVCs in knowledge-intensive functions. The paper therefore discusses the role of both knowledge flows within global pharmaceutical R&D value chains as well as national innovation systems on the development of capabilities of Chinese and Indian CROs. Our analysis is based on data from semi-structured interviews collected from senior R&D managers from a sample of ten US and European pharmaceutical MNCs and owners and senior R&D managers from five Chinese and five Indian CROs who are providing research services to MNCs in this industry. We discuss the emergence of R&D outsourcing in this industry and the nature and mechanisms of knowledge flows within R&D value chains. The embeddedness of CROS in the national innovation systems of their home countries is also discussed.

Application and use of isothermal calorimetry in pharmaceutical development

There are many steps involved in developing a drug candidate into a formulated medicine and many involve analysis of chemical interaction or physical change. Calorimetry is particularly suited to such analyses as it offers the capacity to observe and quantify both chemical and physical changes in virtually any sample. Differential scanning calorimetry (DSC) is ubiquitous in pharmaceutical development, but the related technique of isothermal calorimetry (IC) is complementary and can be used to investigate a range of processes not amenable to analysis by DSC. Typically, IC is used for longer-term stability indicating or excipient compatibility assays because both the temperature and relative humidity (RH) in the sample ampoule can be controlled. However, instrument design and configuration, such as titration, gas perfusion or ampoule-breaking (solution) calorimetry, allow quantification of more specific values, such as binding enthalpies, heats of solution and quantification of amorphous content. As ever, instrument selection, experiment design and sample preparation are critical to ensuring the relevance of any data recorded. This article reviews the use of isothermal, titration, gas-perfusion and solution calorimetry in the context of pharmaceutical development, with a focus on instrument and experimental design factors, highlighted with examples from the recent literature. © 2011 Elsevier B.V.