Changes in roll-your-own tobacco and cigarette sales volume and prices before, during and after plain packaging legislation in the UK.

BACKGROUND: Plain packaging and minimum pack size legislation for tobacco products was introduced in the UK in May 2016, with a 1-year sell-off period until May 2017, during which both fully branded and plain packs of various sizes were legally available. This study investigates trends in prices of roll-your-own tobacco (RYO) before, during and after implementation of this legislation, and compares trends with those observed in the cigarette market. METHODS: We used Nielsen Scantrack data for the period from March 2013 to June 2018 to describe trends in UK inflation-adjusted prices and volumes of both RYO and cigarettes, and linear regression to estimate changes in prices associated with the introduction of plain packaging and the minimum pack sizes of 30 g RYO and 20 cigarettes. RESULTS: In contrast to a downward trend in cigarette sales volumes, RYO volumes rose throughout the study period. By the time plain packs accounted for 75% or more of sales, the average price of products sold in equivalent pack sizes had increased, relative to average prices in the year before implementation and with adjustment for tax changes, from 34.9 to 38.8 pence per gram for RYO (mean difference 4.26, 95% CI 3.99 to 4.53 pence, 12% increase), and from 38.6 to 41.13 pence for cigarettes (mean difference 2.53, 95% CI 2.24 to 2.83 pence, 7% increase) per cigarette. CONCLUSIONS: New legislation resulted in higher prices for RYO and manufactured cigarettes. However, sales volumes of RYO continued to increase throughout the study period, perhaps because RYO remains a less expensive means of smoking tobacco.

Exploring new packaging and delivery options for the immunization supply chain.

A variety of vaccine packaging and delivery technologies may benefit the immunization supply chain. These include alternative primary packaging, such as blow-fill-seal polymer containers, and novel delivery technologies, such intradermal delivery devices, microarray patches, and sublingual formulations of vaccines, and others in development. The potential timeline to availability of these technologies varies and depends on their stage of development and the type of data necessary to achieve licensure. Some new delivery devices are anticipated to be introduced in 2017, such as intradermal devices for delivery of inactivated poliovirus vaccine to stretch vaccine supplies due to a supply limitation. Other new technologies requiring vaccine reformulation, such as microarray patches and sublingual vaccines, may become available in the long term (2021 and beyond). Development of many new technologies requires partnership between vaccine and technology manufacturers and identification of the applicable regulatory pathway. Interaction with public-sector stakeholders early on (through engagement with forums such as the World Health Organization's Immunization Practices Advisory Committee Delivery Technologies Working Group) is important to ensure suitability for immunization program use. Key considerations for programmatic suitability of a new vaccine, packaging, and delivery device include cold chain volume, costs, and health impact.

[Tafluprost--a novel prostaglandin F2alpha analogue].

The review provides a brief history of the evolution of ophthalmic containers: from glass vials to plastic bottles with obligatory preservatives and, finally, to preservative-free polypropylene single-use single-dose tubes. A brief characteristic of benzalkonium chloride, the most commonly used preservative, including mechanisms of its antiseptic activity and ocular toxicity is given. The problem of ocular surface damage, especially in glaucoma patients, due to the long-term use of preserved eye drops, is discussed. Pharmacodynamics of tafluprost, the first commercially available preservative-free single-dose prostaglandin analogue, is described. Operating characteristics of experimental preclinical studies and the first three phases of clinical trials of tafluprost are provided. Post-approval studies of the comparative efficacy and tolerability of the new drug are analyzed and its prospects for clinical use are assessed.

2012 drug packaging review: many dangerous, reportable flaws.

Drug packaging plays an important role in protecting and providing information to patients. The packaging examined by Prescrire in 2012, on the whole, still fails to perform all of these functions effectively. Two issues are especially worrisome. First, packaging too often poses a danger to children. In addition, too many patient leaflets provide incomplete information about adverse effects, thus failing to properly protect the most vulnerable patients. Yet, the method Prescrire used to analyse drug packaging shows that it is not difficult to detect and anticipate risks. It is up to healthcare professionals to take advantage of the method, to protect patients from, and report, dangerous packaging.

Development of biotechnology products in pre-filled syringes: technical considerations and approaches.

A monoclonal antibody (mAb) product development case study is presented to address some of the issues faced during developing a pre-filled syringe (PFS) product for a biotherapeutic. In particular, issues involving incompatibility with silicone oil and a stability-based approach for selection of PFS barrel and tip cap components have been discussed. Silicone spiking studies followed by exposure to agitation stress or accelerated temperature conditions were used to check for incompatibilities of the mAb with silicone oil, a necessary product contact material in PFS. In addition, screening studies to compare various closure materials as well as syringe barrel processing methods were used to select the optimum closure materials as well as the correct syringe processing method. Results indicate that the model mAb formulation used was sensitive to high levels of silicone oil especially under accelerated temperature conditions resulting in formation of protein-silicone particles in the solution for samples that were spiked with the silicone oil. Agitation stress did not have any significant impact on the quality attributes tested. Samples stored in syringe barrels that were processed with sprayed-on silicone had higher levels of subvisible particles as compared to those that were processed with the baked-on process. The tip cap comparability study resulted in one tip cap material having superior compatibility among the three that were tested. The quality attribute that was most impacted by the tip cap materials was mAb oxidation. An approach for evaluation of primary packaging components during the development of pre-filled syringe presentations for biotechnology-based compounds has been highlighted.

[Current perspectives on the repackaging and stability of solid oral doses]. / Déconditionnement et stabilité des formes orales sèches solides: états des connaissances.

Which are the guidelines and scientific aspects for repackaged oral solid medications in France in 2010 whereas it develops? The transient or definitive displacement of the solid oral form from the original atmosphere to enter a repackaging process, sometimes automated, is likely to play a primary role in the controversy. However, the solid oral dose is to be repackaged in materials with defined quality. Considering these data, a review of the literature for determination of conditions for repackaged drug stability according to different international guidelines is presented in this paper. Attention is also paid to the defined conditions ensuring the conservation and handling of theses drugs throughout the repackaging process. However, there is lack of scientific published stability data. Nevertheless, recent alternatives may be proposed to overcome the complexity of studying stability in such conditions. Then, the comparison of the moisture barrier properties of the respective package, a galenic model of hygroscopic molecules, or light sensitive molecules or stability data obtained during the industrial preformulation phase could also secure the list of drugs to be reconditioned. Similarly, a wise precaution will be to get stability data for the industrial blisters and unit doses undergoing the real conditions of the medication use process in hospitals and other healthcare settings. By now, reduction of dispensing errors and improvement of the compliance aid put a different perspective on the problem of repackaged drugs. To date, the pharmacist is advised to carry out its analysis of the risks.

Formulation and manufacturability of biologics.

An important challenge in the pharmaceutical development of a biologic is the optimization of safety and efficacy while ensuring the ability to manufacture the drug while maintaining quality and stability. The manufacturing process consists of several operational steps referred to as 'unit operations' where the biologic is subjected to different stresses and conditions that may compromise quality and stability. Moreover, recently the requirement for the development of subcutaneous formulations for high dose drugs, such as monoclonal antibodies, at high protein concentrations has created additional challenges for many of the unit operations. These challenges can be mitigated by modification of the manufacturing process and/or development of formulations to prevent degradation. In particular, formulations have been designed to minimize protein aggregation and decrease viscosity, which has led to successful manufacture of the biologic.

Current perspectives on stability of protein drug products during formulation, fill and finish operations.

Commercialization of protein-based therapeutics is a challenging task in part due to the difficulties in maintaining protein solutions safe and efficacious throughout the drug product development process, storage, transportation and patient administration. Bulk drug substance goes through a series of formulation, fill and finish operations to provide the final dosage form in the desired formulation and container or delivery device. Different process parameters during each of these operations can affect the purity, activity and efficacy of the final product. Common protein degradation pathways and the various physical and chemical factors that can induce such reactions have been extensively studied for years. This review presents an overview of the various formulation-fill-finish operations with a focus on processing steps and conditions that can impact product quality. Various manufacturing operations including bulk freeze-thaw, formulation, filtration, filling, lyophilization, inspection, labeling, packaging, storage, transport and delivery have been reviewed. The article highlights our present day understanding of protein instability issues during biopharmaceutical manufacturing and provides guidance on process considerations that can help alleviate these concerns.

Top ten hot topics in parenteral science and technology.

Ten current "hot topics" in parenteral science and technology are reviewed to update the reader on current advances and challenges with each topic. Topics selected are formulation advances, packaging advances, extractables and leachables, analytical method advances for biopharmaceuticals, protein pharmaceutics, quality by design, manufacturing and equipment advances, aseptic processing advances, rapid microbial methods, and visual inspection of parenteral products.

Bar-coded medication administration (BCMA) systems. Future promise, present challenges.

One popular new method for building safeguards into the medication administration process is the use of a bar-coded medication administration (BCMA) system. Clinician use the system's bar-code scanner to scan labels on the medication packaging and on the patient's identification wristband. In this way, the system verifies that administered medications match provider orders at the point of care. BCMA systems have received a lot of media attention and manufacturer promotion. However, they aren't yet a practical option for most hospitals. Although they offer great potential to help prevent administration errors, current systems have significant limitations. To realize maximum patient safety benefit, an ideal BCMA system should be capable of both point-of-care medication verification and automatic programming of infusion pumps. No current system offers both capabilities. In this article, we discuss these and other limitations and list objectives that need to be met to make commercial BCMA systems successful. We also give advice to help hospitals reduce medication error now and prepare for future implementation of integrated BCMA systems.

[Packaging issues during the development of a medicinal product]. / La problématique du conditionnement au cours du développement d'une spécialité pharmaceutique.

When it specifies the medicinal product, the article L.5111-2 of Code de la santé publique refers first of all to its "special packaging". The packaging, integral part of the medicinal product, does not only ensure its identification, it takes a decisive participation in maintaining drug quality and integrity; and moreover it facilitates its administration, therefore its good use, as well as its therapeutic observance. During the future drug development, the packaging is going to change, according to the development's phases, to lead to the final presentation which will be precisely described in the marketing authorization application. The packaging "cahier des charges" must be developed very early in order to guarantee drug quality and if needed, functionality of the device during storage. So it is a key element of drug preservation, which must be compatible with the market distribution. The pharmacist has to his disposal many kinds of material which can be used: glass, various plastic materials, aluminium, alumino-plastic complex, elastomers. Some examples highlight the industrial, security, prescription and administration aspects which must be taken into consideration during the development of a medicinal product in order to obtain the marketing authorization application, then to ensure permanence of drug qualities during its marketing.