Low-dose capsule filling of inhalation products: Critical material attributes and process parameters

Faulhammer, Eva; Fink, Marlies; Llusa, Marcos; Lawrence, Simon; Biserni, Stefano; Calzolari, Vittorio; Khinast, Johannes G.

doi:10.1016/j.ijpharm.2014.07.050

Cited by 46 publications

(26 citation statements)

References 33 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, lowdose filling leads to challenges during manufacturing. Modern capsule-filling technologies [173][174][175] take into account these challenges and apply special adjustment to the machines for accurate dosing. For example, high-end continuous dosator machines like the Planeta 100 ( Fig.…”

Section: Low-dose Fillingmentioning

confidence: 99%

An Overview of Pharmaceutical Manufacturing for Solid Dosage Forms

Sacher

Khinast

2016

Methods in Pharmacology and Toxicology

Self Cite

View full text Add to dashboard Cite

In this chapter, the main processing steps and manufacturing aspects of solid dosage forms are described and the relevant literature is reviewed. Starting with powder feeding, powder blending, granulation (dry and wet), and drying the most important unit operations to make compactable granules are reviewed. As an alternative to granulation, hot-melt extrusion is introduced, together with the various downstream processing choices. Next, tableting and capsule filling-for making a final dosage form-are discussed, followed by a section on coating. In all sections scale-up methods are reviewed and an outlook for future developments is provided. The last two sections are devoted to process analytical technology (PAT) and continuous manufacturing.

show abstract

Section: Low-dose Fillingmentioning

confidence: 99%

An Overview of Pharmaceutical Manufacturing for Solid Dosage Forms

Sacher

Khinast

2016

Methods in Pharmacology and Toxicology

Self Cite

View full text Add to dashboard Cite

show abstract

“…The resulting optimum blends were experimentally tested and the optimization results validated. This proposed methodology was further evaluated to accelerate product development while minimizing required experimentation and raw material consumption [144,175].…”

Section: Product Formulationmentioning

confidence: 99%

Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture

Ierapetritou¹,

Ramachandran²

2016

Methods in Pharmacology and Toxicology

View full text Add to dashboard Cite

“…Another aspect is the increasing fraction of high-potency active pharmaceutical ingredients (HPAPI) in the development pipelines with only a few mg of active substance in the formulation [1]. Direct dosing of API into capsules [2] [3], generating low-dose blends for HPAPIs [4] [5] and creating seeding strategies for crystallization processes [6] [7] are just a few instances in which robust powder feeding at feed rates of several milligrams per second is required. In addition, in several flow chemistry applications, direct powder feeding into a fluid stream would eliminate sampling issues associated with feeding from a reservoir suspension [8]- [10].…”

Section: Introductionmentioning

confidence: 99%

Continuous feeding of low-dose APIs via periodic micro dosing

Besenhard

Karkala

Faulhammer

et al. 2016

International Journal of Pharmaceutics

View full text Add to dashboard Cite

Precise and effective feeding of small powder quantities remains a challenge in many fields, including pharmaceutical development and production. This paper demonstrates that a simple feeding principle can be applied to accomplish stable micro feeding (<100mg/s) and describes a gravimetric powder feeding system with a vibratory sieve mounted on a chute. Feeding was induced via vertical vibrations that can be adjusted within a broad range of frequencies and amplitudes. The feeding system was studied using different frequencies, amplitudes, sieves and powder properties. Feeding was characterized by means of a dynamic scale and high-speed camera recordings. The feeding system provided effective powder feeding even in a range of 1-2mg/s. It was shown that powder properties require special attention when the vibratory sieve-chute system operates at higher feed rates (or feeding times >30min), i.e., feeding at a higher throughput. A combination of discrete element method (DEM) simulations and compartment population balance model (PBM) was used to incorporate the proposed micro feed system into a continuous powder mixer (Gerike GCM250; Gerike Holding LTD., Regensdorf, Switzerland). It illustrates how oscillating feeding rates (the latter is a characteristic of the studied micro feeding system) affect the content uniformity of low dose blends, i.e., powder mixtures with a relatively low fraction of active pharmaceutical ingredient.

show abstract

Low-dose capsule filling of inhalation products: Critical material attributes and process parameters

Cited by 46 publications

References 33 publications

An Overview of Pharmaceutical Manufacturing for Solid Dosage Forms

An Overview of Pharmaceutical Manufacturing for Solid Dosage Forms

Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture

Continuous feeding of low-dose APIs via periodic micro dosing

Contact Info

Product

Resources

About