Premium Pharmaceutical Excipients
pharm-a-spheres™ Sugar Spheres
The Ideal Starter Core for Sustained-Release Pellet Formulations
Our sophisticated combination of technological capabilities and analytical expertise enables us to fulfill precise particle size specifications. Our specialized in-house laboratory, dedicated exclusively to sugar sphere analysis, guarantees conformity to all standards and provides comprehensive certificates of analysis with detailed characteristic data.
Superior Quality
High sphericity and mechanical strength for consistent coating results.
International Compliance
Fully conforming to Ph.Eur., USP/NF, and other international pharmacopoeias
Natural Ingredients
Made exclusively from sucrose, corn (maize) starch and purified water
Comprehensive Size Range
Available from 100 µm to 2 mm (microspheres to standard spheres)
FDA Documentation
Drug Master File (DMF) available
Quality Assurance
ISO 9001 certified, IPEC GMP compliant manufacturing
Advanced Manufacturing & Testing
Our sugar spheres represent the gold standard in pharmaceutical excipients, offering exceptional sphericity and mechanical strength unmatched by competing products. Manufactured through a unique, highly controlled process, pharm-a-spheres™ are the optimal choice for multiparticulate oral drug formulations, especially with sustained or controlled-release drug formulations.
Available in 18 Standard Sizes – from 106 µm to 2000 µm, with customized sizes available upon request.
We know our business
10 Reasons to Choose Our Pharmaceutical Sugar Spheres
01
High mechanical stability, no attrition, low friability
Due to their special manufacturing process pharm-a-spheres™ sugar spheres have a high mechanical stability. Even when coated influidized-bed equipment the pharm-a-spheres™ sugar spheres do not disintegrate and form no
attrition.
02
High degree of sphericity, non-porous surface, smooth surface
Also as a result of the production process the pharm-a-spheres™ sugar spheres show a high degree of sphericity. Even the small-sized microspheres have a non-porous, smooth, and spherical surface. This is important for a precise layering with API and reproducible release of the final pellet.
03
Outstanding microbiological quality
The pharm-a-spheres™ sugar spheres excel by an outstanding microbiological quality. The reason is the use of high-quality excipients, thermal process steps, and long term production experience.
04
All-natural ingredients, digestible, biodegradable
The pharm-a-spheres™ sugar spheres consist of all-natural ingredients. Sucrose and corn starch are natural substances, also present in our daily food. They are digestible and biodegradable. By the way: The small amounts of these substances administered with the final drug are irrelevant as far as diabetes or dental caries are concerned.
05
Tailor-made, reproducible particle size distribution
The particle size is often a critical parameter in the customer’s coating process. Our company is specialized to offer pharm-a-spheres™ sugar spheres with a tailor-made and reproducible particle size distribution. This is possible by longterm experience with the sizing, classification, and particle size analysis of this product.
06
Worldwide acceptance, easy registration for regulatory drug applications
Pharm-a-spheres™ sugar spheres conform to the pharmacopoeial monographs for sugar spheres in the USP/NF, EP, CP, JPE and others. Production and testing is according to the IPEC GMP guidelines. These are the preconditions for the worldwide acceptance and easy registration for any regulatory drug applications.
07
Active ingredients are not involved in the forming process
The use of pharm-a-spheres™ sugar spheres as core for subsequent layering with API and sustained release excipients is a smart alternative to the manufacturing of API pellets. The active ingredient is not involved in the manufacturing process which is connected with several advantages. You can minimize losses of precious API, save thermal and chemical deterioration of the active ingredient, and start with a defined surface area for reproducible coating.
08
Chemically indifferent excipients, no incompatibilities
The excipients of the pharm-a-spheres™ sugar spheres are chemically indifferent and incompatibilities with the active ingredients are unlikely or may be solved by simple technological measures. There is really no need to use spheres of any other composition. Organic solvents are not used neither in the manufacturing process of the spheres nor in the production of its excipients.
09
Competitive prices, flexible service, delivery in time
Considering the high quality of the pharm-aspheres™ sugar spheres our prices are more than competitive. Accurate delivery in-time of the ordered quantities is a duty for us.
10
More than 50+ years of experience
More than 50+ years of experience with the manufacturing and testing of pharm-a-spheres™ sugar spheres for numerous customers guarantee the best solution for your application. A large in-house laboratory equipped with sophisticated instruments allows us a fast release process and provides reliable results of even special parameters. Technological experience from numerous applications is available for your assistance. Please challenge our capabilities.
Download our complete brochure
Download the complete brochure with detailed information about our quality advantages and production competence.
Made in Germany. Family Values.
Rooted in more than six decades of tradition, pharm-a-spheres™ is a family-owned business that combines the precision of German pharmaceutical manufacturing with a personal commitment to quality that no corporation can replicate.
Globally Compliant.
Our products meet the requirements of all major international pharmacopoeias – including Ph.Eur., USP/NF, JPE (Japanese) and ChP (Chinese) Pharmacopoeia – and are supported by an FDA Drug Master File, giving our customers worldwide the regulatory confidence they need.
Science-Driven Expertise.
Decades of experiences in manufacturing sugar spheres, helps to have extensive manufacturing skills. In case you have problems at your side, our dedicated team can assist in application support.
Your Specifications. Our Commitment.
Whether you require a standard catalogue size or a fully customized solution, our dedicated team and specialised in-house laboratory are here to meet your exact production requirements – reliably, flexibly and with uncompromising quality.
In house laboratory.
Thanks to an internal lab, testing can be done quickly and without being depended on third party. If any additional parameters are required in the certificate of analysis (CoA), we can easily provide them.
FAQ about our products
FAQ: Sugar Spheres, Neutral Cores & Alternative Excipients
Find quick answers to the most common inquiries about our products and quality standards.
What is the most common composition of neutral spheres used as core for active pellets?
Sucrose and corn starch are substances also commonly used as food ingredients and widely available in the necessary pharmaceutical quality. They are natural substances made from sugar beet or sugar cane and maize. Sucrose and starch are safe, non-toxic excipients. In the intestine they are digestible, and in the environment completely biodegradable. This meets the customer’s expectation for clean label products.
Sucrose is related to dental caries and diabetes, isn’t it?
Sugar spheres become part of an orally administered drug form that is swallowed (as hard gelatine capsules or matrix tablets). There is no relevant contact to the teeth. The total quantity of sucrose in the daily doses is neglectable in comparison to the carbon hydrates in the food and has no adverse effect on patients suffering from diabetes.
Any technological good reasons to make spheres from sucrose and starch?
Indeed, building-up the spheres by crystallization of sucrose enables us to manufacture mechanically very resistant particles. Attrition and breakage in the course of further processing are significantly reduced in comparison to spheres made by agglomeration of insoluble substances with the help of binding agents.
We want the spheres dissolve clearly in water…
Sucrose is easily soluble in water, but corn starch forms a cloudy suspension. When swallowed, this is completely irrelevant. However, if spheres are meant to get dissolved prior to use, we recommend the larger globuli sacchari, made solely from soluble sucrose, as alternative.
Does the hygroscopic starch interfere with water-sensitive active substances?
Definitely, no! The sugar spheres are dried in the manufacturing process to a water activity below 0.6. The residual water is bound firmly to the starch and is not available for chemical reactions. Furthermore, it would be possible to insulate the spheres’ surface prior to coating with sensitive API.
I heard about MCC spheres …
MCC is microcrystalline cellulose. There is no economic, chemical nor technological reason to use these instead of the proven sugar spheres. A saving of time in the coating process is a rumor.
Some applications need spheres made of tartaric acid?
There are formulations on the market that combine the API load on the spheres with pH lowering tartaric acid as core to improve the solubility and bioavailability of the drug substance. In this case we propose a combination of sugar spheres coated with API and sugar spheres coated with tartaric acid, combined in the same capsule.
Okay, I am nearly convinced, but the registration documents do not cover this alternative!
Let’s talk about scientific facts, not formal pseudo-problems.
What is your personal opinion about all this?
After more than 50+ years of worldwide experience with sugar spheres I can honestly summarize, that there was no pellet formulation task that could not be solved with sugar spheres. Spheres of other composition were often defeated and had their specific own problems like availability, purity, stability, and others.