Tag Archives: PROCAPS

SPOTLIGHT INTERVIEW WITH CLAUDIA SILVA – NEW PLATFORMS DIRECTOR – PROCAPS

Leave a comment

A conversation with Claudia Silva, New Platforms Director at Procaps 

Senior researcher with experience on formulation, development and industrial transference for new products, integrates her background and expertise in rheology of natural hydrocolloids leading the Project Management on New Platforms for Research, Design and Development of new delivery systems and new pharmaceutical dosage forms, the evaluation of new materials, equipment and technologies as innovative proposals and the evaluation of gelatin substitutes for product development. 

BRW: What do you hope the audience will learn from this webinar?

At Procaps, we aim that this webinar can give the audience a close insight on vegetarian soft capsules, the options that are currently available, some features of the materials and the manufacturing process, the product development process and the differences in product performance as well as stability.

BRW: What discussions do you look forward to having with the audience?

We are looking forward to share experiences, assets and drawbacks as well as get to know the audience´s expectations when developing products under the vegetarian soft capsules platform.

BRW: What do you enjoy most about your role?

The most I enjoy about my role is that everyday there is something new to learn and there are always new challenges. I work with a team that makes results possible with commitment, enthusiasm and hard work.

BRW: How did you get into the industry?

After studying polymers abroad I returned to Colombia moving from the academy to the industry with the expectations of translating knowledge into solutions. At Procaps I’ve had the chance to do it based in its culture of innovation and transformation, working with challenging Projects and new technologies.

BRW: Where is your favourite place in the world and why?

My favorite places are the ones that I’ve had the chance to live in detail. Living in Barranquilla 5 years now, I can say that the city has experienced many positive changes about infrastructure and investment. It is my second home and it is one of my favorite places because it is always sunny, warm, quiet but changing.

Abroad, Santiago de Compostela, Spain where I studied is a charming place with history, many cultural activities and a universitary lifestyle that brings to me great memories. It is a place for enjoy and coming back always.

Join Claudia Silva on a webinar entitled Vegetarian Soft Capsules: Unlocking the Power of a Versatile Technology by Procaps on 26th November at 3PM London/10AM New York.

Register Here!

 

Stability Issues Related to Soft Gelatin Capsule Development

Leave a comment

Procaps Webinar

Stability issues are a challenge and never ending concern for formulators. The reactivity of formulation depends on many factors, but it is generally recognized that labile drugs in aqueous forms are sometimes the worst case scenario, and this should be a true statement for the development teams that work with softgel development. Although product development has been described by many authors as a cycle, we would refer to it as a tower, where pillars are the preformulation phase. Most of the reference information about the API(s) and the excipients are gathered at this stage in order to guide the next steps and to build the product documentation for filing. What was not disclosed is that based on that definition, preformulation would be highly consuming in both time and resources in order to guarantee success at the final product. It was only stated many years later by introducing the QbD concept!

It would help to illustrate the concept, thinking about the preformulation phase as the way to solve the incognita ABC through the equation: A+AC+B+BC=ABC, being A the fill formulation, C the stability conditions (temperature, humidity, light), B the gelatin formulation and ABC the softgel product. In the same way, since the gelatin softgel is a primary packing for the medicine, it would also help to apply the same reasoning of packing development to formulation development. Then, why is it not the same criteria applied to gelatin formulations since they are the primary packing of the drug? Using the same packaging, would be a particular gelatin formulation proper to any climate conditions?

Formulation of pharmaceutical products has been considered a tailor-made approach for each product and according to this, defining a formulation guide is somewhat controversial. However, to establish a guide with multiple considerations on formulation is a great help as the first step to discard predictable incompatibilities and to avoid the most common formulation non-compliances. Here, a starting point would be to define the complexity of the system: Is a same gelatin formulation indicated to formulate both hydrophilic and lipophilic fill contents? On the other hand, some incompatibilities are difficult to detect at a lab. Usually, there is a constraint to obtain capsules at a small scale, to test the system as a whole and evaluate migration phenomena: one of the causes of the most of the defects in softgels (dissolution non-compliance, opacity, blooming, etc). Then, the question is what to do? What are the lab tests and the analytical tools that help to make it easier? Shortcuts are highly desirable therefore we will discuss them in our upcoming webinar.

What about the timings? From the beginning we anticipated that preformulation in spite of being the safe side, is a time consuming phase. In this regard, one of the questions needed to be considered would be: In a project framework, how much time is foreseen to cover difficulties in preformulation? Here, using a weighted punctuation for the product complexity to estimate formulation times would be a recommended approach. What about the scale? Is there any way to make preformulation at lab conditions or will final results depend on final capsules? Here, there is another concern in the way to make preformulation as profitable as it could be and that is to determine if lab tests correlate well with pilot scale (adding more work!). In general, it could be reliable at least to test the excipients, when process parameters are kept as controlled as possible at a lab scale.

What about the results? We started the QbD framework some years ago and what we´ve learned about gelatin preformulation is the importance of consolidating the lessons, building the decision diagram and feeding the formulation bank. This includes the criteria for the selection of a gelatin formula or another, on a general basis as well as in some specific cases. The QbD approach offers an exploration space that covers the most relevant aspects of development. It is important to bear in mind that this approach doesn´t guarantee that you don´t have to go back during the process, but if it happens, you will certainly return with qualified information. This gives you a criteria of what to do and what not to do, as well as the knowledge of what are the most probable causes of non-compliance. In brief, it is for sure a matter of time: the saved time from non-compliances and reformulation!

Finally, as the purpose of this space is to share knowledge and experiences, we would like to hear from you regarding the questions stated above as well as your own questions. To learn more insights on this matter join us in our upcoming webinar on Application of QbD principles in the development of the gelatin shell formulation of softgels.

Register now here.

For more information on our company and services visit www.softigel.com or contact us at [email protected]

Claudia Silva, New Platforms Development Director from Procaps

Leave a comment

Claudia procaps - spotlight

Claudia graduated from Universidad Nacional (Colombia) gaining a degree as a Pharmacist. She also holds a European PhD in Food Science and Engineering from Universidad de Santiago de Compostela in Spain.

Claudia went on to become a senior researcher with experience in formulation, development and industrial transference for new products. This integrates her background and expertise in; rheology of natural hydrocolloids, leading the project management on new platforms for research, design and development of new delivery systems and new pharmaceutical dosage forms, the evaluation of new materials, equipment and technologies as innovative proposals and the evaluation of gelatin substitutes for product development.

Claudia has authored several scientific research papers and attendant to various International Congresses in the area of rheology and research and development of thickening systems.

1. Why did you decide to do a webinar with us?

The decision was the result of some criteria such as the support in the pharmaceutical community (pharmaceutical editors), the hosting services, the sort and quality of media sources, the ranking and our experience as attendants in different webinars in BRW platform. All these aspects were considered as relevant to our purpose to offer a space on sharing different technical standpoints and hold fruitful discussions on current subjects that concern the global pharmaceutical industry

2. How did you get into the industry?

I have been working with Procaps for 4 years now. I was part of the R&D team in the nutritional gummies facility and then moved to the Headquarters to lead the team of New Platforms, having the opportunity to deal with the newest Product Developments. It has been the role that has allowed to me to combine the background in Pharmacy and the expertise on natural polymers rheology.

3. What do you most enjoy about your role?

The most rewarding experience of this role is to learn new things each time and to access to specific and detailed knowledge. Our team believes that most things are possible and that our main objective is to make them real.

4. What motivates you?

I am motivated by being involved in creative processes and thinking about different ideas, challenging situations and competitions. Through that, I have learned that to overcome difficulties, persistence, patience and optimism are required. During my free time, I enjoy taking part of writing competitions, trying new things and working with a theater group, activities that include some of these motivations. At work, they have been a driving force to find different ways to solve particular problems and keep working on successful projects.

5. What has been your best holiday and where would you recommend visiting?

Taking holidays is a whole process. I enjoy planning as well as travelling and coming back home. All the holidays have been different and therefore unique. I lived in Spain for some years and there is always a reason to come back there. I recommend Santiago de Compostela and Seville, both quite different but charming.

Claudia will be presenting with Diego Monterroza in Procaps webinar ‘Preformulation and formulation activities during development of soft gelatin capsules’ on the 30th April at 3PM London/10AM New York.

Diego Monterroza, Corporate R&D Manager at Procaps

Leave a comment

Diego procaps - spotlight2

Diego holds a degree in Organic Chemistry from Universidad del Atlántico and a Master’s degree in Pharmaceutical Sciences from Universidad Nacional in Colombia. He has more than 15 years of formulation and analytical development experience with soft gelatin capsules products, including products for the US, EP and Canadian markets.

Diego has led formulation development for liquids, semisolids, and suspensions, contained in soft gelatin capsules, including lipid formulations and self-emulsifying drug delivery systems. In his current role, Diego leads the product and analytical development of pharmaceutical products for PROCAPS S.A. covering diverse solid and liquid dosage forms, mainly, soft gelatin capsules and associated technologies.

1. Why did you decide to do a webinar with us?

The decision was the result of some criteria such as the support in the pharmaceutical community (pharmaceutical editors), the hosting services, the sort and quality of media sources, the ranking and our experience as attendants in different webinars in BRW platform. All these aspects were considered as relevant to our purpose to offer a space on sharing different technical standpoints and hold fruitful discussions on current subjects that concern the pharmaceutical industry

2. How did you get into the industry?

I have been at Procaps for about 15 years passing for different areas like QC, Tech Services, Analytical Development, Regulatory Affairs and now Product Development. Through this time I have been in contact with regulations from several countries including LATAM and highly regulated markets, working interesting and challenging formulations in softgels and advanced technologies for big pharma companies and many other customers located in more than 42 countries.

3. What do you most enjoy about your role?

The possibility of facing new challenges adapted to the specific requirements of customers and regulatory entities. I also enjoy very much leading a multidisciplinary, heterogenic team, dealing with tough requirements and strong positions that need to be agreed through experimentation and science-based decisions.

 4. What motivates you?

The changing challenges that each project represents. The need of applying specific knowledge to each project but at the same time meeting timelines and very strict commitments.

5. What has been your best holiday and where would you recommend visiting?

Best holyday was my honeymoon in Peru. I definitively recommend this country not only places are magical, but the food is incredible and most important, the hospitality of the Peruvians is amazing.

Diego will be presenting with Claudia Silva in Procaps webinar ‘Preformulation and formulation activities during development of soft gelatin capsules’ on the 30th April at 3PM London/10AM New York.