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Your introductory knowledge hub for soft capsules.
What determines the shelf life of softgel capsules?
Understanding the shelf life of softgel capsules can be particularly challenging. This article breaks down the science behind expiration dates in softgel capsules.
Softgel Capsules Explained: The Ultimate FAQ Guide (Part II)
Discover the most frequently asked questions about the intricacies of softgel capsules from the technical point of view.
Softgel Capsules Explained: The Ultimate FAQ Guide (Part I)
Discover the most frequently asked questions from the consumer point of view about softgel capsules.
3 key factors for successful shell development
This article highlights 3 key aspects of shell formulation development, from raw material selection to addressing common compatibility issues. A well-designed capsule shell is the key to unlocking the full potential of the encapsulated fill, ensuring that the product remains stable throughout its shelf life.
Meet the Expert: Dr. Samir Haddouchi
To kick off our Meet the Expert series, we’re excited to feature Dr. Samir Haddouchi, Managing Director at SOTAX Pharma Services (SPS), and a leading expert in dissolution testing of softgel capsules.
Transfer of soft capsule products between 2 CMOs: best practices
The transfer of softgel capsule manufacturing between contract manufacturing organizations (CMOs) is a complex process that is often underestimated.
Choosing the right CDMO partnership model for softgel development
In today's pharmaceutical industry, partnerships between pharmaceutical companies and Contract Development and Manufacturing Organizations (CDMOs) are crucial for the successful development and commercialization of drugs. Choosing a CDMO itself can be a game-changer.
Softgels vs. tablets vs. capsules: what's the difference?
When developing new drug products, pharmaceutical companies often choose between three main dosage forms: tablets, hard capsules, and softgel capsules. This decision is a critical juncture in the development process, as each option has its own unique characteristics and benefits.
SMEDDS in softgel capsules: opportunities and pitfalls
SMEDDS is an acronym for Self Micro-Emulsifying Drug Delivery System. SMEDDS formulations are a clear solution of a drug substance which spontaneously form an oil-in water (O/W) microemulsion upon dispersion in water. In the emulsion the drug substance is incorporated within droplets with a size of 50-200 µm. A SMEDDS formulation typically contains a lipid solvent, one or more surfactants and optionally a co-solvent.
How to select a CDMO for a softgel development project
In the dynamic world of soft gel capsule development, outsourcing to a Contract Development and Manufacturing Organization (CDMO) can be a game-changer. But what exactly should you know before doing so?
This guide breaks down the essential steps to choose the perfect softgel CDMO for your development project.
Latest updates to USP <1094>: key insights for softgel capsules
The United States Pharmacopeia (USP) has recently revised Chapter 1094 (Capsules dissolution and related quality attributes), focusing on capsule dissolution and related quality attributes. The changes came into effect on December 1, 2023.
Below is a concise overview of the significant updates for softgel capsules specifically.
In-process controls (IPC) for soft capsules
While the release tests for solid dosage forms and softgel capsules are typically well defined in the pharmacopeias, IPC testing is rarely discussed. This article gives an overview on the most common IPC testing methods for each step of softgel manufacture.
1. Gelatin mass preparation
As the characteristics of the gelatin mass may impact the processability, appearance and physical stability of the capsules, appropriate IPC testing include the following:
The manufacturing process of softgel capsules
Soft capsules are commercially manufactured applying the rotary-die technology, a technique that traces its roots back to the 19th century with the innovations of the pharmacist Robert P. Scherer. It involves a series of operations which are performed in parallel to each other and are typically highly standardised at each manufacturer: gel mass preparation, filll mass preparation, encapsulation, drying, inspection and (bulk) packaging.
What are softgel capsules?
Soft capsules are a solid oral dosage form a liquid or semi-solid capsule fill containing the active ingredient dosed into a hermetically sealed capsule shell.
While soft capsules have been known and patented first in the 1830s, the most common process for their commercial-scale production, the rotary-die encapsulation, was patented by R.P. Scherrer in 1933.