Environmental Sustainability Assessments of Pharmaceuticals: An Emerging Need for Simplification in Life Cycle Assessments

Soete, Wouter De; Debaveye, Sam; Meester, Steven De; Vorst, Geert Van der; Aelterman, Wim; Heirman, Bert; Cappuyns, Philippe; Dewulf, Jo

doi:10.1021/es502562d

Cited by 36 publications

(35 citation statements)

References 30 publications

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“…This concept offers economic advantages, improved product quality and a lower environmental impact of processing [1,2,3,4]. Moreover regulatory authorities recently recognized the potential of continuous manufacturing and encouraged adoption of it by the pharmaceutical industry [3].…”

Section: Introductionmentioning

confidence: 99%

Improved tabletability after a polymorphic transition of delta-mannitol during twin screw granulation

Vanhoorne

Bekaert

Peeters

et al. 2016

International Journal of Pharmaceutics

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To refer to or to cite this work, please use the citation to the published version:Vanhoorne V., Bekaert B., Peeters E., De Beer T., Remon J.P., Vervaet C. (2016) Improved tabletability after a polymorphic transition of delta-mannitol during twin screw granulation. International Journal of Pharmaceutics 506 13-24 DOI: 10.1016/j.ijpharm.2016.04.025 AbstractIn most formulations processed via continuous twin screw granulation microcrystalline cellulose (MCC) and/or lactose are used as excipients, but mannitol is also a preferred excipient for wet granulation and tableting due to its non-hygroscopicity and inertness.Therefore, the aim of the current study was to investigate the influence of process parameters on critical quality attributes of granules (moisture content, solid state, morphology, size distribution, specific surface area, friability, flowability and hygroscopicity) and tablets (tensile strength and friability) after twin screw granulation of δ-mannitol. The δ-polymorph was selected since a moisture-induced transformation to β-mannitol was observed during batch wet granulation, which exhibited a unique morphology with a large surface area and improved tabletability. A full factorial experimental design was performed, varying screw speed (400 -900 rpm), granulation temperature (25 -40 °C), number of kneading elements (6 or 12) and liquid-to-solid (L/S) ratio, on the granulation unit of a ConsiGma TM -25 line (a continuous powder-to-tablet manufacturing system). After tray drying the granules were milled and tableted. The results showed that the polymorphic transition from δ-to β-mannitol also occurred during twin screw granulation, although the residence time and L/S ratios were much lower in continuous twin screw granulation compared to batch processing. However, the polymorphic transition was not complete in all experiments and depended on the L/S ratio, screw speed and number of kneading elements. Nevertheless all granules exhibited the unique morphology linked to the polymorphic transition and had a superior tabletability compared to granules produced with β-mannitol as starting material. This was attributed to enhanced plastic deformation of the granules manufactured using δ-mannitol as starting material. In addition, it was concluded that mannitol was granulated via a different mechanism than other, lesssoluble, excipients (e.g. lactose, microcrystalline cellulose) due to its high solubility and dissolution rate as the influence of process parameters on the mannitol granule characteristics was different.

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Section: Introductionmentioning

confidence: 99%

Improved tabletability after a polymorphic transition of delta-mannitol during twin screw granulation

Vanhoorne

Bekaert

Peeters

et al. 2016

International Journal of Pharmaceutics

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“…This concept offers economic advantages, improved product quality and a lower environmental impact [17,18,19,20]. However, up to now only two studies addressed continuous granulation of formulations with HPMC [21,22].…”

Section: Introductionmentioning

confidence: 99%

Continuous twin screw granulation of controlled release formulations with various HPMC grades

Vanhoorne

Janssens

Vercruysse

et al. 2016

International Journal of Pharmaceutics

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HPMC is a popular matrix former to formulate tablets with extended drug release. Tablets with HPMC are preferentially produced by direct compression. However, granulation is often required prior to tableting to overcome poor flowability of the formulation. While continuous twin screw granulation has been extensively evaluated for granulation of immediate release formulations, twin screw granulation of controlled release formulations including the dissolution behavior of the formulations received little attention. Therefore, the influence of the HPMC grade (viscosity and substitution degree) and the particle size of theophylline on critical quality attributes of granules (continuously produced via twin screw granulation) and tablets was investigated in the current study. Formulations with 20 or 40% HPMC, 20% theophylline and lactose were granulated with water at fixed process parameters via twin screw granulation.The torque was influenced by the viscosity and substitution degree of HPMC, but was not a limiting factor for the granulation process. An optimal L/S ratio was selected for each formulation based on the granule size distribution. The granule size distributions were influenced by the substitution degree and concentration of HPMC and the particle size of theophylline. Raman and UV spectroscopic analysis on 8 sieve fractions of granules indicated an inhomogeneous distribution of theophylline over the size fractions. However, this phenomenon was not correlated with the hydration rate or viscosity of HPMC. Controlled release of theophylline could be obtained over 24 h with release profiles close to zero-order.The release of theophylline could be tailored via selection of the substitution degree and viscosity of HPMC.

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“…Even though the supply would theoretically be completely secured, companies might be resistant to data sharing in order to preserve their competitive advantage in the global environment [14]. However, well considered business models can ensure process data sharing with a certain degree of aggregation and black box modelling throughout the SC to enhance the use of primary process data of suppliers for e.g., sustainability assessments through Life Cycle Assessment (LCA).…”

Section: Supply Chain Reliabilitymentioning

confidence: 99%

“…While correlations models of processing data with environmental data can be made with R, SPSS or any program for statistical analysis, Life Cycle Inventory (LCI) databases are commonly working with extensions such as .xml (extended mark-up language), ecospold (ecoinvent database format), .olca (OpenLCA database format), etc. [14,28]. To convert LCI databases to work with in different software packages, so-called converting tools were developed (e.g., the ones from the European Commission's Directorate-General Joint Research Centre) [28].…”

Section: Different Languagesmentioning

confidence: 99%

“…Product and organizational sustainability could be quantified using organizational operational data in a customized ERP module, as has been proposed by De Soete et al (2014) [14]. The authors provide correlations between the environmental impact of products as response variable and readily available ERP data as candidate predictor variables.…”

Section: Introductionmentioning

confidence: 99%

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Towards a Multidisciplinary Approach on Creating Value: Sustainability through the Supply Chain and ERP Systems

Soete

2016

Systems

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Abstract:Manufacturing Resource Planning (MRP) is a widely used approach through manufacturing environments in a variety of sectors. With a tendency to go to specialized, smaller lot sizes in several industries (e.g., the pharmaceutical sector), companies are dealing with capacity bottlenecks if the planning rhythm wheel is not well calibrated or when production lines are not flexible enough in terms of changeover (C/O) and set-up times (S/U) (OEE is too small). A well-established communication system including other enterprise resources or production factors (e.g., Enterprise Resource Planning, ERP) is favorable to any extent. More and more questions arise from stakeholder communities and end-users on whether or not supply chains and manufacturing environments are sustainable and safe. Departments such as Environmental Health, Safety & Sustainability (EHS & S) and Product Stewardship are too often at the "blind" side of the ICT interface. When it comes to product and organizational sustainability, data seems to be lacking in order to conduct sustainability assessments proficiently. Years of intensive research and experience proved that primary data to perform sustainability assessments often are measured through equipment control sensors (e.g., flow rates, temperatures, etc.) and sent to PLCs and many other systems. Nevertheless, these data measurements are in many cases simply not penetrating through the Manufacturing Execution Systems (MES) because these bottom-up engineering data seems to be of little value to planning, procurement, etc. This communication paper deals with how sustainability assessments can be embedded in business operational management systems. After all, who does not want a "live Carbon Footprint" for process improvements and external sustainability reporting instead of a series of expensive resource consuming studies of 4 to 6 months digging into data logs in traditional Life Cycle Assessment (LCA)? This communication paper has taken one step further in coupling business ERP systems with environmental sustainability of products, services and enterprises.

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Environmental Sustainability Assessments of Pharmaceuticals: An Emerging Need for Simplification in Life Cycle Assessments

Cited by 36 publications

References 30 publications

Improved tabletability after a polymorphic transition of delta-mannitol during twin screw granulation

Improved tabletability after a polymorphic transition of delta-mannitol during twin screw granulation

Continuous twin screw granulation of controlled release formulations with various HPMC grades

Towards a Multidisciplinary Approach on Creating Value: Sustainability through the Supply Chain and ERP Systems

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