(PDF) GRANULATION TECHNIQUES: AN …
Granulation, the process of particle enlargement by agglomeration technique, is one of the most significant unit operations in the production of pharmaceutical dosage forms, mostly tablets and ...
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Chapter 2 Metal Injection Molding (MIM) Processing
2.2 Metal Injection Molding 2.2.1 MIM Process Metal injection molding (MIM) is an advanced manufacturing technology that uses the shaping advantage of injection molding process to be applied to metal. The process has ability to produce the high degree of geometrical complexity of the component with high properties.
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Validation and Routine Operation of a Sterile Dry Powder Filling
A facility for the filling of a sterile dry powder antibiotic is described. The facility comprises the tunnel concept for washing and sterilization of the product containers, a filling unit under laminar airflow with localized vacuum exhaust, a changing room suite, autoclave, airlock, and conventional clean room containing the filling equipment. The need to reduce the …
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Process Validation of Ceftriaxone and Sulbactam Dry Powder Injection
Process Validation of Ceftriaxone and Sulbactam Dry Powder Injection
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(PDF) Pharmaceutical Powder Dosage Forms: A Review
Abstract. A powder is a solid state fine dry bulk, composed of particle of varying shape, grain size, and flow properties. Despite the desirable properties of being in fine size, but it has ...
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Dry powder filling machines » Syntegon
Sterility matters across the entire aseptic process – before, during and after sterile filling. Syntegon offers internal and external cleaning machines for vials and other containers. Once the vials have been pre-cleaned with …
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Product Development Issues of Powders for Injection
dry-powder drug into presterilized vials (see Figure 2, Strategy 2). The dry-filling process also is much more cost effective be-cause it requires less infrastructure as well as a reduced amount of energy and a shorter amount of time to produce a batch (4). These reasons have made dry-filled PIs a popular dosage form.
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Dry-Powder Formulations for MAbs
Previous research into dry-powder biopharmaceutical formulation has focused largely on nasally delivered vaccines and pulmonary-directed antivirals and antibiotics. But such drugs remain underrepresented among marketed products ( 1–4 ). Inhalable MAbs have even further to go to reach patients, although the COVID-19 …
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Spray Freeze-Drying as a Solution to Continuous Manufacturing …
Pharmaceutical manufacturing is evolving from traditional batch processes to continuous ones. The new global competition focused on throughput and quality of drug products is certainly the driving force behind this transition which, thus, represents the new challenge of pharmaceutical manufacturing and hence of lyophilization as a …
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Full article: Preparation, characterization, and pharmacodynamics of
Dry powder inhalers ... Repose angle of INS@FDKP-MPs was 33.1° lower than 35° which met the requirements of the industrial production process and the Carr's index also shows satisfied flowability with value 21.7% smaller than 22%. ... Compared with insulin for injection, the duration of the powder was shorter than that of subcutaneous ...
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Frontiers | Formulation of Dry Powders for Inhalation Comprising …
Spray-dried formulations of a hydrophobic, crystalline drug, GDC-A, were prepared using the suspension-PulmoSphere™ technology. Increases in drug loading resulted in decreases in the primary particle size distribution and increases in tapped density. This enabled fine particle doses of up to 25 mg to be achieved with a portable dry powder inhaler from a …
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Annex 6 WHO good manufacturing practices for sterile …
WHO good manufacturing practices for sterile pharmaceutical products 1. General considerations 2. Quality control 3. Sanitation 4. Manufacture of sterile preparations 5. …
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Injection Molding
Newtonian Viscosity. Generalization: Injection molding. "Shear Thinning". ~ 1 sec-1 for PE. Typical shear rate for Polymer processes (sec)-1. Extrusion Calendering. 102~103 10~102 Injection molding 103~104 Comp. Molding 1~10 16.
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Powder Processing of Bulk Components in Manufacturing
The primary benefits of powder forming are as follows: (a) reduced forming temperature (reduced energy cost), (b) capability for engineered porosity, (c) elimination of mold component reactions caused by melt forming, and (d) suitability for mass production of small metal components and ceramics of all shapes and sizes.
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(PDF) Product development issues of powders for …
Powders for injection (PIs) are a popular parenteral dosage form for drugs that cannot be marketed as ready-to-use injectables …
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Fundamentals of Freeze Drying
A Closer Look at the Freeze-Dry Process • Freezing – Solidify the contents of every vial • Primary drying – Remove, by sublimation, the ice from the frozen matrix. This occurs by bulk flow from a region of higher pressure (the surface of the ice in the product vial) to a region of lower pressure (the chamber). • Secondary drying
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Powder Processing in Pharmaceutical Applications—In-Depth …
A whole process chain from transfer of suspension to dry powder by freeze drying and comminution through a sieve over blending with tableting excipients to …
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Inhaled SARS-CoV-2 vaccine for single-dose dry powder aerosol …
An inhalable, single-dose dry powder aerosol SARS-CoV-2 vaccine shows good storage stability, results in sustained antigen delivery to antigen-presenting cells in the lungs and induces a potent ...
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Frontiers | Optimizing the design and dosing of dry …
Thermostability is one of the product characteristics preferred by WHO for vaccines against respiratory infections due to ease of administration, pain minimization, and low costs. Thermostable dry …
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Manufacturing of Parenteral Preparations (Injections, Large Volume
Manufacturing Process: Manufacturing of sterile products shall required defined conditions and environment. 10. Form-Fill-Seal Technology or Blow, Fill-Seal Technology: Form-Fill-Seal units are specially built automated machines in which through one continuous operation, containers are formed from thermoplastic granules, filled and …
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IN-PROCESS QUALITY CONTROL: A SYSTEMATIC …
The FPP are the products of all categories which has undergone all stages of manufacturing process, including packaging in its final container and labelling. The function of In-process quality control is to monitor and if necessary modification and adjustment of the manufacturing process in order to comply with the specifications.
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Active Ingredients Management And Material Quantity Calculation …
For this demo, i am taking a scenario of Dry Powder Injection, its a pharmaceutical product. Scenario of this product is very much different than other Pharma Products e.g Tablet, Capsule. Batch size is not fix in dry powder injection products; BOM components are mostly limited to one raw material only, There is no major processing …
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Chapter 13 Formulation Development of Parenteral Products
understand the process of developing an optimized formulation in a laboratory. understand the process of transferring and scaling up the new formulation to a large-scale …
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Physical stability of dry powder inhaler formulations
Effect of powder production methods on stability of dry powder inhalers Drug particles for DPIs can be produced using different particle processing techniques, as shown in Figure 1 . The aerosol performance of dry powder inhalers can be significantly impacted by changes in morphology, size, surface energy and surface composition of the …
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Product development issues of powders for injection
The preformulation, formulation, pack selection, and process scale-up issues to be considered for the development of stable and efficacious Pls are traced. Powders for injection (Pls) are a popular parenteral dosage form for drugs that cannot be marketed as ready-to-use injectables because of their instability in an aqueous environment. Pls are …
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Classification of powders for injection. | Download …
Jan 2002. Arvind Kumar Bansal. Powders for injection (PIs) are a popular parenteral dosage form for drugs that cannot be marketed as ready-to-use injectables because of their instability in an ...
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Role of RH and Temperature in Dry Powder Injection Manufacturing
The Role of RH and temperature in dry powder injection manufacturing is therefore to facilitate the production of high-quality powder that will not only work excellently but that will also last long without reducing quality. ... There are standard requirements for every powder injection manufacturing so it is good to check before starting the ...
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Spray dried powders for nasal delivery: Process and formulation
The most important factor to consider on nasal powder manufacturing is ensuring particle size suitability, to guarantee deposition on the nasal cavity. Formulation strategies include: engineered microparticles of the appropriate size [API-only or API and excipient (s)], powder blends and chimeral agglomerates (Table 3) [16], [168], [185], [188].
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Overview Development and Manufacturing of Injectable …
The administration of drugs to humans through injection was first recorded as early as the mid-1800s; however, little was known about microorganisms at the time, so safely …
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Process Validation of Ceftriaxone and Sulbactam Dry …
Abstract. In the present work Process validation of Ceftriaxone and Sulbactam as a dry powder injection was carried out. As the manufacturing process of dry powder injection is mainly dependent on blending process. In the present investigation, blending process was validated at different speeds of blender and the % assay was estimated by HPLC ...
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