INSIGHTS ON SOLID DOSE MANUFACTURING
-
An Alternative Method Of Drug-Excipient Characterization
Isothermal microcalorimetry (IMC) rapidly screens API-excipient compatibility, detecting physical and chemical interactions faster than conventional methods, saving time and effort in pharmaceutical formulation development.
-
Closing The Duration Gap In FDA-Approved Long-Acting Contraceptives
A gap exists between three months and three years in FDA-approved long-acting contraceptives (LACs). A microsphere formulation enables sustained release over a six to twelve-month period.
-
Cytiva's Aseptic Filling Workcell User Group
Discover how global collaboration among aseptic filling experts is driving innovation and improving operations.
-
Seizing Market Share Pre-Patent Expiry: The Evolution Of A CDMO Partnership In Navigating A Paragraph IV ANDA Submission
The dynamic pharmaceutical landscape demands agility and strategic foresight. Explore how leveraging a key partnership helped to overcome a looming patent expiry for a second-generation acne medication.
-
Improving API Solubility Using Hot Melt Extrusion Formulation2/27/2025
Solubility of active pharmaceutical ingredients (APIs) is a challenge in drug development. Discover how hot melt extrusion with polyvinyl alcohol enhances API solubility and stability to offer improved drug delivery.
-
When To Consider Material And Personnel Airlocks For Downflow Booths3/20/2026
Strategic use of airlocks in downflow booth design enhances pressure stability and containment. A risk-based approach ensures facility integration meets rigorous safety and compliance standards.
-
Safely Scaling High Potency API Manufacturing4/13/2026
Scaling HPAPI production demands disciplined containment and exposure control. Integrated operating models help manage risk while enabling compliant, reliable scaleāup.
-
5 Advancements In Tablet Compression That Pharma Can't Ignore In 202611/4/2025
New materials, smart automation, and in-press quality control are optimizing tablet compression. These five key innovations are driving efficiency and consistency in solid dose manufacturing today.
-
Lower Punch Tip Bending / Buckling11/11/2024
When manufacturing mini-tablets, adjusting punch force ratings is crucial to prevent bending or buckling. The Rankine-Gordon formula offers a safer force rating for microtip tooling.
SOLID DOSE MANUFACTURING SOLUTIONS
-
With many of the blockbuster biologic drugs of the ’90s are coming off of patent, companies are racing to provide a clinically similar alternative to these pioneering products. Like any biologic drug, they require care and attentiveness throughout the manufacturing process. Therefore, it is necessary to maintain aseptic conditions throughout the production process of these drug products.
-
Basic Powder Flow Characterization [USP <1174>]:
A powder flow analysis is an indicator of how well formulation will release from the hopper during the tableting. It is important to know that the developed formulation is showing ‘Mass Flow’ or ‘Funnel Flow’ or ‘Rat Holing’.
Powder blend shows ‘Mass Flow’ when the entire solid bed is in motion during the discharge of material from the outlet. This is a ‘First-in-First-Out’ process. Hoppers offering ‘Mass Flow’ have steep and/or low-friction walls. This flow offers ‘No-Arching’, ‘Less Segregation’, and ‘Stable Powder Flow’.
When the hopper is not sufficiently steep and smooth enough to ensure sliding along its wall, the powder blend exhibit ‘Funnel Flow’. Such hoppers are sensitive to arching and ratholing. In this case, powder discharge from the hopper is not predictable.
-
Isotube is an effective option for the safe loading and charging of multiple drums of HPAPIs. Compared to the DCS® Drum Containment System for safely discharging drums, it is the preferred choice when charging lumpy and agglomerated products as a lump breaker system can be included in the lower part of the discharge hopper.
-
Used 79 gallon (300 liter) Inox reactor, stainless steel construction, approximately 24" diameter x 34" straight side, dish lid top with dish bottom, jacket and interior rated 30 psi and full vacuum at 300 F, 6" top access, with (1) 4", (1) 3", (2) 2" and (2) 1.5" nozzles on top, with bottom entering magnetic agitator, .75 hp with controls, 1.5" center bottom outlet, with load cells, all on portable frame, serial# 95011-2, CRN# K82555, built 1995.
-
The big bag emptying stations of Dec are based on a modular design. This allows to be ideally equipped with systems for each product’s characteristics with corresponding docking systems for non-potent to highly active powders. Depending on the product flow, there is a range of discharge devices or lump breakers available. With the use of load cells, it is possible to dose accurately into the receptacle.