A selection of articles from European Pharmaceutical Review covering Ingredients, Excipients and Dosages:


European experts meet with Afican regulators to discuss collaboration

10 March 2017  •  Steve Bremer, Managing Editor

Representatives from the European Medicines Agency (EMA) met with medicines regulators from Africa last week to discuss how to improve the availability of high quality, safe and effective medicines to patients in countries beyond Europe. One of the tools discussed was the scientific assessment of medicines or vaccines for use outside the European Union that […]

How digital transformation drives change and collaboration in the laboratory

8 September 2016  •  Dassault Systèmes BIOVIA

This webinar shows how Lonza’s Specialty Ingredients sector successfully digitised and unified their global research operations with BIOVIA solutions...

New third-party audit scheme for excipient suppliers

New third-party audit scheme for excipient suppliers

22 October 2015  •  Iain Moore, President, EXCiPACT asbl

There has always been a regulatory requirement for pharmaceutical manufacturers to audit their starting material suppliers, but the expectations are even clearer now that these audits, including those for excipients, have to be in vivo. With increasing requirements for physical audits, can all pharmaceutical companies address the number of audits within a realistic frequency? Equally, suppliers of excipients to their many pharmaceutical customers face an avalanche of audits. With both sides having limited resources is there a third-party audit solution which meets regulatory expectations and is efficient in resources?

Dynamic vapour sorption of freeze-dried pharmaceuticals

Dynamic vapour sorption of freeze-dried pharmaceuticals

22 October 2015  •  Claudia Kunz and Henning Gieseler, Department of Pharmaceutics, University of Erlangen

Freeze drying is gaining in importance as the number of biopharmaceuticals that are unstable in a solution increases. According to recent reports, a growth of 10% may be expected for freeze-dried products in the next 10 years. The technique offers the opportunity to gently dry temperature-sensitive drugs such as proteins or peptides. Since freeze drying is a rather expensive drying technology, formulation and process optimisation strongly focus on the design of a robust and fast cycle. Interestingly, partially crystalline systems offer advantages with regard to processability as well as product appearance...

The SSPC: leading the way for next-generation medicines manufacture

The SSPC: leading the way for next-generation medicines manufacture

3 September 2015  •  Benjamin K. Hodnett, Anita R. Maguire, Pat J. Guiry, Ake C. Rasmuson, Brian Glennon and Abina M. Crean - SSPC

The Synthesis and Solid State Pharmaceutical Centre (SSPC), a global hub of pharmaceutical process innovation and advanced manufacturing, is funded by Science Foundation Ireland (SFI) and Industry, and represents a unique collaboration between 22 industry partners, nine research performing organisations and 12 international academic collaborators. It is a €42 million state-industry investment, which supports a globallyleading research team of 38 investigators, 34 post-doctoral researchers and 60 PhD candidates. As the largest research collaboration in Ireland and one of the largest globally within the pharmaceutical area, the SSPC transcends company and academic boundaries. Its role is to link experienced scientists and engineers in academia and the pharmaceutical industry, to address critical research challenges and to deliver industry-relevant solutions, which result in job growth and retention within the pharmaceutical industry...

Dennis Douroumis

Hot melt extrusion processing for the development of sustained release products

15 April 2014  •  Dennis Douroumis, Reader in Pharmaceutical Sciences at the University of Greenwich and the Director of Centre for Innovation in Process Engineering and Research

Hot Melt Extrusion (HME) has attracted increased interest for the development of pharmaceutical dosage forms over the last decade. It is a versatile processing technology which produces extrudates in the form of solid dispersions and solid solutions. Among the various applications, HME has been adopted for the development of sustained release dosage forms by using a wide range of pharmaceutical excipients such as polymers or lipids. In this review, we highlight the development and recent trends of sustained release dosages manufactured by extrusion processing.

Pills Powder

Excipients in medicines for children: scientific and regulatory paradigms

15 April 2014  •  Ali Al-khattawi, Postdoctoral Research Associate, Aston University / Afzal R. Mohammed, Senior Lecturer in Pharmaceutics, Aston University

There is an ongoing debate over the use of pharmaceutical excipients in medicines for children, triggered by the increased number of formulations suitable for this target patient population. Pharmaceutical excipients can be regarded as essential / necessary enablers in formulation development. These are materials other than the ‘active pharmaceutical ingredient’ which are added to the formulation to achieve a specific function. This may include aiding in the processing or manufacture of the drug delivery system such as lubricants or flow aids, controlling the release of the active ingredient to achieve modified release, enhance patient acceptability by improving taste of medicines or to develop easily swallowed dosage forms.


Excipient selection in biologics and vaccines formulation development

19 February 2014  •  M. Babu Medi and Ramesh Chintala, Vaccine Drug Product Development, Merck & Co, Inc and Akhilesh Bhambhani, Novel Adjuvants, Formulation and Delivery Technologies, Merck & Co, Inc.

Excipients are an integral part of pharmaceutical products and play an important role in the formulation development of both small and large molecule pharmaceuticals. The type and extent of excipient use depends on several factors, including the type of active ingredient, route of administration, dosage form, target population and indication and so forth. With a growing number of protein therapeutics and vaccines in development, stabilisation during processing and storage presents a major challenge for the pharmaceutical industry. Biologics and vaccines are inherently unstable and prone to degradation by several physical and chemical degradation mechanisms. Therefore, a variety of excipients are required to stabilise biologics and vaccines during processing and storage. Selection and use of the appropriate excipients enable development of novel therapies and robust pharmaceutical products. The purpose of this article is to present an overview of the challenges associated with biologic and vaccine formulation development as well as different types of excipients used to stabilise these products.

Ingredients: In-depth focus 2013

13 June 2013  •  Matt Moran, Paul E. Luner

Revisiting a mutual recognition agreement approach for GMP inspections to secure the safety of the supply chain of APIs.
Solid form diversity of commonly used tableting excipients and its impact.

The central role of excipients in drug formulation

18 April 2013  •  Pascal Furrer, Pharmacist

Active substances are rarely administered alone. For example, levothyroxine, a synthetic form of the thyroid hormone, indicated in the treatment of hypothyroidism, is administered at a very low dosage, ranging from 15 μg to 200 μg. These very small amounts of powder mean that it is not possible to manufacture tablets containing only this drug. Hence, the formulation of levothyroxine tablets requires the combination of the hormone with one or more nonmedical agents known as pharmaceutical inactive ingredients or excipients that serve varied and specific pharmaceutical functions1.

Breaking old habits: Moving away from commonly used buffers in pharmaceuticals

10 July 2012  •  David Sek, Research Scientist, Pfizer

One of the key factors in stabilising proteins is determining the optimal pH and buffer system to provide adequate solubility and stability. Currently, three buffers, citrate, phosphate and acetate, make up the majority of buffers used in parenteral pharmaceuticals approved by the FDA, but less precedented excipients are certainly available to use in commercial dosage forms. A number of alternative buffers have also gone through the approval process to be proven safe, and the use of histidine and tromethamine is becoming increasingly common in parenteral formulations. This article highlights the advantages of some lesser known buffers with the hope that bringing these excipients into the clinic and market more often will help to augment the tools formulators have available in achieving stable protein formulations. The US Food, Drug and Cosmetic Act of 1938 required manufacturers and pharmaceuticals companies to be responsible for the safety of drug additives / excipients in their products in response to a tragedy where 100 children were killed from the presence of diethylene glycol in an antibacterial product. To help clarify what is needed to establish a new excipient, the FDA released a guidance document in 2005 entitled ‘Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients’, outlining the safety studies needed in order to have an excipient approved1,2. Recent articles have called for the need for more alternative excipients for the use in formulations1,3,4.

Figure 1 Examples of chemical structures of antibodies for targeted pulmonary inhalation aerosol

Pulmonary inhalation aerosols for targeted antibiotics drug delivery

16 February 2011  •  Chun-Woong Park & Heidi M. Mansour, University of Kentucky, College of Pharmacy and Don Hayes Jr, University of Kentucky, College of Medicine

Targeted pulmonary drug delivery of antibiotics by inhalation aerosols can play significant roles in the treatment of cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD) and in other pulmonary diseases where chronic airway infections exist. Direct administration to the lung as targeted pulmonary inhalation aerosol delivery is uniquely able to provide for high dose levels of drugs at the target site of action without systemic side effects. This review presents an overview of pulmonary inhalation aerosols, types of inhalation aerosols, aerosol formulation additives and present current research in the targeted pulmonary drug delivery of antibiotics for the treatment of pulmonary infections. Clinical trials of antibiotic inhalation aerosols are also discussed.


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