Solids Development Consult GmbH

Formulation Development in Safe Hands

Working Together With Experts for Pharmaceutical Formulation

We are experts for formulation development. Not only in theory but also in practice. We assist you on specific issues in pharmaceutical formulation. We can also support you by conducting particular trials or even by taking care of the entire formulation development. Our lab provides the equipment required for all relevant trials. We can get started promptly as we aren‘t bound to any GMP regulations in our lab. This allows us to quickly obtain conclusive results for you.

We developed a method that allows us to obtain reliable results even with a very little amount of API. We call this method „Small Scale Development“. Using this method, we save up to 90 % of API compared to conventional early-stage procedures and still make valid predictions about tabletability and future producibility. We‘d love to explain this method to you in a personal conversation to give you an impression of the small scale pharma industry . Just give us a call!

Small Scale Development – Precise Trials for Pharmaceutical Formulation

The „Small Scale Development“ method enables us to perform many trials relevant for the pharmaceutical formulation at a very early stage of drug development — exactly during the phase when the API is still very costly and produced only in limited quantities. Your advantage: The possibility to determine the basics of formulation and production method even prior to clinical trials can reduce the time for market access considerably.

We develop pharmaceutical formulations for:

• direct tableting
• dry granulation
• fluid bed and
• high shear granulation

We can apply our „Small Scale Development“ to all these procedures. Naturally, we also support you during transitions in manufacturing processes or with other challenges connected to formulation development, for example if you already have a pharmaceutical formulation and wish to optimize it.

Once the formulation is established, we do not leave you high and dry: We also perform scale-ups, define manufacturing instructions including in-process controls, and supervise the transfer to production sites.

Our Procedure in Formulation Development – We Solve Your Individual Challenges

First of all, for a successful formulation development we want to fully understand your situation and the precise challenges. On this basis, we will work out a proposal for solution. This proposal greatly depends on the type of problem and will be tailored individually for you. Below, you can see our basic model for formulation development which is based on three central phases:

Coming Soon: Testing Substances in an OEB-5 Lab

Our custom-made laboratory for HPAPI is currently under construction.

At Solids we work with substances of different OEB levels. In future, we will be able to extend our portfolio even to services for HPAPI and OEB-5. Soon, you will be completely unrestricted in the choice of your substances, and we will be able to use not only substances of an OEB level of 3 or 4 but also of a level of 5.

You are invited to directly send us a request about OEB-5 and HPAPI as well as regarding the capacities of our workspaces. We'll support you with your trials – no matter which OEB level.

Mastering Scale-up for Tablet Compression in a Few Steps

With Solids the Scale-up of Your Pharmaceutical Projects Will Succeed

In the process of tablet compression, the scale-up can be challenging – but not with Solids. We have the experience and expertise for a successful scale-up of pharma products and we know exactly what to consider regarding the compression of tablets. Whether dry granulation, fluid bed granulation or high shear granulation – we have the know-how for an optimal scale-up of pharmaceutical products and advise you in tablet compression. Just contact us – we accompany your scale-up.

Experts for a Successful Scale-up – Less Trials in Tablet Compression

First, the procedure for scale-up depends on the technology employed. For example, with dry granulation the scale-up can be conducted very logically as we know all the relevant parameters. The key influencing factors force, gap and roll speed can be calculated for scale-up and the scale-up process does not involve many trials for a successful compression of tablets.

Whereas with high shear granulation the influencing factors are known, too, but cannot be forecast for the scale-up as easily. In general, the process requires more trials to be conducted. However, our experience comes into effect here and allows us to keep the number of trials and the materials input to a minimum. In terms of complexity, fluid bed granulation is in-between dry granulation and high shear granulation.

Troubleshooting Production

Troubleshooting tablets considered as Out-of-Specification

We Find Individual Solutions for Your Samples

We are experts of pharmaceutical technology, and we know how to combine knowledge of substances and formulation with insights into processes and technology. In many cases, issues arising in production are a combination of both sides. Problems, for example tablet defects as capping, laminating, oos or sticking, can occur not only in context of a change or innovation within the manufacturing procedure but also suddenly and against expectation. Please, give us a call! We can help you with troubleshooting tablets that are e.g. considered as Out-of-Specification — fast and without red tape.

Difficulties in Production Such as Out-Of-Specification: We'll Find the Solution

In troubleshooting, there is no standard solution – not for tablet capping, laminating, sticking, or Out-of-Specification. Every difficulty is individual and requires a customized approach to solution. Only then a smooth production in pharma can be guaranteed.

During a free initial consultation, we can discuss your situation and try to narrow down the problem of tablet defects. As the case may be, we can give you some ideas how the problem could be solved. We can easily arrange an appointment for an initial consultation, or you just give us a call.

Discreet and on Short Notice – In That Way We Help You in Your Production

Naturally, we observe silence about any content discussed. For an initial consultation, we usually don‘t need to know precise names of API or product. They can remain anonymous. To explore the source of the difficulty we might want to know certain product properties. We do not see the need for a confidential disclosure agreement at this point. This way, we are ready to start right away. However, if you prefer, we can sign a CDA beforehand. schnell und unbürokratisch loslegen. Natürlich sind wir aber auch bereit ein CDA abzuschließen.

Depending on the urgency and the problems‘ nature we can also arrange to come to your site on short notice. Most production challenges can be solved best with troubleshooting tablets on-site. Sometimes, minor details in handling can already make all the difference.

If time is not as crucial, we will design an approach to resolve the problem after our first consultation. In many cases, we will contact you with some more queries. The extraordinary challenge with production issues is that the solution has to be found within very tight limits. Major changes must be authorized We prefer to spare you this effort and the high cost involved. We will discuss the proposal for solution with you and answer your requests directly.

We Find Individual Solutions That Help You Quickly

In some cases, it makes sense to conduct some preliminary trials in our lab. Such pretrials allow us to better analyze the cause of any issues and tablet defects. Key advantages of troubleshooting are:

• Less material for pretrials
• No blocking of production capacities
• No batches Out-of-Specification

Findings from pretrials to avoid defects of tablets or Out-of-Specification can then be adapted to your production. Of course, we assist in monitoring this transfer to your site. There are also cases where pretrials have no benefits. Then we favor finding a solution together and directly on-site. The purpose of all approaches is to ultimately develop a solid solution for the long-term —despite the generally serious time pressure.

Of course, we document all trials and stages of troubleshooting tablets for you and can write a comprehensive report if you wish for it.

We are ready if you need our help with production problems such as production outage, blocked batches, or Warning letter. Together we‘ll find solutions for seemingly insoluble problems.

The Optimal Pharma Instrumentation for Full-Featured Pharma Equipment

Upgrade Your Pharma Equipment and Instrumentation With Solids

It is our aspiration to comprehend and investigate the relationships between pharmaceutics and technology more deeply and to find the most efficient solutions for full-featured pharma equipment. For this purpose, we cooperate with universities, we conduct our own contract research, and we supervise bachelor, master, and doctoral theses in the topics of pharmaceutical technology such as tablet press instrumentation.

Improved Pharma Instrumentation for Higher Product Quality

By means of instrumentation (e.g. tablet press instrumentation) and measurement technology within pharma equipment, we observe single aspects within the manufacturing process of solid dosage forms. The choice of aspects depends on the actual question, and the findings usually allow us to improve regulating and monitoring of the process and of pharma equipment itself. This ultimately leads to an increase of product quality – for your trials, studies, and productions for any tablet sizes and for constant tablet measurement.

Your Trials With Experts for Pharma Equipment Instrumentation

We closely cooperate with mechanical engineers within the pharmaceutical field to deepen our expertise in pharma equipment. Here, we concentrate on optimizing individual machines, facilities for continuous manufacturing, and research into innovative measurement methods. Finally, the process needs to be stabilized to produce tablets with constant tablet measurements.

Depending on the question, machines can be equipped with additional force transducers and displacement measurement systems. Acquisition and evaluation of measurement data and its implementation to machine control can play a decisive role for content uniformity.

In addition, we developed an external data acquisition software for tableting presses that enables us to verify the internal machine software‘s measuring procedures and measurement data and to improve it accordingly. This external software can be used universally for all tableting presses.

We Handle Your Data With Respect – Just Like Your Projects Due to their innovative nature, many cooperative research projects are subject to non-disclosure. Naturally, we respect this, and we cover these projects only with the client‘s explicit consent. Check out our blog for further information on tablet press instrumentation and news from our team.

Have you come up with an idea? Do you need support for its execution or evidence of relevance? Or are you simply looking for a partner to discuss your ideas? Give us a call. We help you to find the best instrumentation for your pharma equipment (e.g. tablet press instrumentation) for your trials.