The purpose of this study is to determine the critical process parameters that impact the spray dried particle’s characteristics by generating powders using a pressure nozzle in a small-scale spray dryer. The focus will be on formulations related to amorphous solid dispersions (ASDs). Operating at small scale during the process development phase is very important for many ASD formulations as the APIs are often very expensive.
In the previous study, we introduced a new powder layering technology as a timesaving method to solve the issue of the enormous amount of time required for fine particle coating. In the past, we selected Acetaminophen (APAP), which is a water soluble API, as the API to be layered.
In this study, we used Ethenzamide (EZ), which is less soluble in water, as a model API to confirm the versatility of the powder layering method.
Manufacturing of coated solid dosage forms entails the deposition of different materials onto substrate cores, such as powder particles, granules, pellets, tablets and capsules, with the aim of improving organoleptic and aesthetic characteristics, providing physical and chemical protection or modifying the drug release profile [1]. Traditional coating techniques involve the use of polymeric formulations dissolved or dispersed in aqueous or organic solvents. In recent years, layering of powder has emerged as a useful alternative for depositing polymeric layers onto coating cores avoiding organic solvents and/or reducing drying process. This technique becomes particularly interesting in the manufacturing of high-level coated products as it allows to shorten the processing time and avoids problems typical of the processes of liquid-based stratification [2]. This is the specific case relating to the preparation of pulsatile release systems consisting of a drug-containing core coated with a relatively thick layer of high viscosity polymers (>50% weight gain). The reference apparatus to realize coating on small cores is represented by the bottom-spray fluid bed, also known as Wurster insert. Aim of this study was to evaluate and compare the performances of two different coating techniques in fluid bed dryer for the preparation of pulsatile drug release minitablets coated with hypromellose. Solution coating in bottom-spray insert and powder layering in tangential-spray insert were studied.
This study aimed to prove that particle sizes could be measured accurately in line with roll compaction when compared to offline measurements and determining the resulting physical characteristics such as flowability and density.
The purpose of this study was to identify the critical process attributes needed to switch from a high shear wet granulation batch process to a twin-screw wet granulation continuous process.
The Wurster Pro provided two major advantages over the standard Wurster process. It allowed the anti tacking agent, talc, to be removed from the coating solution and added in a powder form. It also permitted processing at an increased spray rate and thus, reduced the overall processing time. The Wurster Pro process was scalable and highly reproducible.
NIR spectroscopy provided significant advantages over offline moisture measurement in terms of time required for sample analysis without a drop off in accuracy. This allows real time moisture data to be taken throughout the entire batch without the need for sampling the product and allowing for quicker responses to process upsets than would otherwise be possible with traditional offline moisture measurements.
The evaluation of the tableting properties of granulates obtained by roller compaction (RC) of binary mixtures prepared with different contents of paracetamol fine powder and using different commercial types of mannitol
A new pharmaceutical water dispersible coating product has been formulated, which is useful for low temperature processes. Trials have been held at laboratory and production scale in order to assess equivalent finished coated product. During the coating process, the tablet bed temperature was maintained at temperatures lower than 30oC…
The main purpose of this investigation was to demonstrate the use of an NIR filter photometer as an in-line process analytical tool to monitor and characterize absorbances for various events (binder addition, powder addition, equilibrium state, etc.) throughout the dry powder-layering process.
The main purpose of the present study was to continue the investigation using placebo blends and commonly used active pharmaceutical ingredients to further ascertain the suitability of the NIR filter photometer for the in-line measurement of moisture during rotor granulation.
Following the FDA’s PAT (Process-Analytical-Technology) initiative in the early 2000s, numerous studies have been conducted utilizing full spectrum near infrared (NIR) sensing technology to monitor moisture in granulation and drying processes….
Evaluate different commercial grades of mannitol to be used in dry granulation by roller compaction (RC), for comparing the compactability of dry granules obtained.
The issue with Mesalazine is that’s its mostly supplied as very fine powder with extremely poor flowability, and wet granulation is most often used to meet the challenge. However, Mesalazine is prone to degradation by several pathways (e.g. oxidation to oxidation and forms quinoneimine), especially if brought into contact with water.
To follow the coating pan process by means of NIR technology and to determine the weight gain and the coating thickness of the coated tablets in real time.
Three different spherical core materials for use in API layering processes; sugar/starch spheres, microcrystalline cellulose (MCC) spheres and novel maltodextrin/starch (M/S)
spheres were coated with 40% Acetaminophen in a dry powder layering process. The three core materials were evaluated both before and after the drug layering for sphericity, aspect ratio, particle size distribution and friability. The novel maltodextrin/starch spheres either equaled or out-performed the more established sugar/starch and MCC spheres in each category.
To develop and introduce several novel processing methods which can be done with conical rotor technology. These methods include spherical granulation, powder layering, and solution/suspension coating.
To develop a method to quickly and efficiently coating dry polymer onto beads using rotor processing without the use of organic solvents.
Challenges exist in developing a robust continuous twin screw granulation process. One of the past challenges encountered has been the formation of “noodle-like” granules at the end of the extruder.
Since most pharmaceutical ingredients (API) have low density and poor flowability, wet granulation is practiced extensively for ease of handling. Wet granulation can be achieved by means of high shear mixers, fluid beds and twin-screw granulators.
