Hey Future4200,
I am looking to consult with an individual who has significant experience making softgel capsules. I’ve never made softgels at any capacity, and I want to learn quickly. I have experience in pharmacy, formulation chemistry, and am great at hitting my head against the wall until I figure things out.
I’d like to see examples of softgel products you have made, general TEK, formulation advice, recommendations on types of gelatin (preferred vegan), and future formulation troubleshooting. Once I have a runway I should be able to get to the finish line without too much continued support so I don’t imagine this is a large workload.
I have worked with people on Future who can vouch for me as a client. I’m not looking to take anybody for a ride nor am I difficult to work with (I hope?). This will not be for the North American market and it will not be for CBD. I intend to make a drug for clinical trials, in a few years, and want to work with somebody who has made cannabinoid softgels as I’ve heard the formulation can be particularly challenging.
If someone who has experience thinks it is easier than I have been lead to believe, please let me know and I will go start failing until I get it right. I appreciate any help on this!
I worked with softgels for clinical trial materials at Catalent. They make a crap ton of these for all kinds of products.
There are solid “vegetarian” polymers available and you can fill them with just about anything. Its all about the filling machine and associated tooling.
With the experience you already have - I cannot imagine any product using softgels would be an issue, as long as you had access to the polymer you wanted (they are commercially available…) and you had a formulation that did not oxidize the specific polymer you choose (there are compatibility tables…).
I find most people that struggle with these established pharma processes do so because they haven’t ever worked with the style of equipment and process validation specifications that come with the territory.
Probably you will not have an issue with this at all. Honestly, the formulation and material extrusion processes are probably the most difficult, and if you have ever done compounding and/or worked with extruded materials for encapsulation or milling, I think you’ve already got 60-70% of what you’ll need to make this work for you.
I don’t know where you want to make drugs for clinical trials - but going with a clinical trial manufacturer comes with benefits… they will already have the equipment, lots of prior formulations, and the infrastructure to get the IND handled and into a clinical trial. Doing all of that yourself, well… I don’t know many small shops that do that.
Feel free to DM me if you want to discuss it a bit more. But really - there are whole books on the topic and it sounds like you have the education/experience to understand them, no problem.
There’s also a softgel course at InterPhex and PackExpo almost every year here in the US. If you wanted to wait a bit and check it out. You just missed PackExpo - it was last month, but InterPhex will be happening in April.
Cassin, thank you for this response. I spent the weekend researching softgels and it was far less intimidating that I originally was thinking. It appears that the biggest challenge is the compatibility of the API/Carrier with the gelatin ,and then how the API/Carrier and gelatin behave within the encapsulation equipment.
We are performing the manufacturing and research at our own facility in Lisbon, and are working on a research grant. Hopefully it pans out and we can attempt this. I wouldn’t say we are particularly large, but we have a great team that has brought a wide range of drugs to market in Europe.
Thank you for sharing the book, I already have purchased it and waiting for its arrival. I will also look into InterPhex. Anything I can do to learn more about this subject I am going to do.
Hi
Please let me know still your are looking for softgel expert?
Mr Niranjn has 21 years rich Pharma experience, developed and delivered many high value and potential products. He worked in pharmaceutical companies like Dr Reddy’s Laboratories (Principal scientist (Associate Director), Sun Pharmaceuticals ltd and Cadila Pharmaceuticals ltd in in solid oral dosage forms and some topical dosage forms.
My self Niranjan (Integra Pharma Consultants) have expertise in soft gel, liquid filled hard Gelatin capsule, Provides technical services, product delivery, Excipient application and troubleshooting of capsules and training to development, production team and providing both technical and strategic inputs.
Having very good project management skills and have very good track record of handling of multiple partners of **CRO/CMOs from US, Europe, Canada and India for delivering products
Please let me know you need in help in softgel related
you can reach out with me @ +91 8008579307. +91 8790759988 mrniru@gmail.com