Market Place
This week, Sunil Kumar Nataraj, technical manager at DFE Pharma, USA and Canada, shares some of the company’s recent innovations in the world of excipients with SpeakPharma.
These innovations improve the drug delivery system, thereby improving adherence of drugs by patients.
Nataraj also talks about DFE’s eStore in the US, and how with the launch of this new e-commerce channel, drug companies will be able to order small quantities of GMP materials, that will be delivered to their doorstep. Excerpts:
Tell us about DFE Pharma’s history and its activities?
DFE Pharma has more than 100 years
of experience in developing and co-developing excipients for the pharmaceutical
industry. In time, some dairy producers transformed into modern suppliers of
lactose excipients.
Our
pharmaceutical grade lactose production started in 1960 and today the lactose products offered
by DFE Pharma are suited for overcoming various manufacturing challenges. For
example, the micro-crystals in our SuperTab® 21AN product offers excellent compaction. The granular nature of our SuperTab® 24AN increases the
compaction further with high drug loading possibilities.
DFE has also pushed the boundary with the launch of SuperTab® 40LL, a co-processed anhydrous
lactose-lactitol product offering compaction levels similar to silicified microcrystalline cellulose
(a widely-used excipient, with high compact-ability)
Since
1985, we have been providing advanced excipient solutions like inhalation grade lactose.
Inhalation
grade lactose is a common and frequently used carrier in dry powder inhalation
formulations. It is popularly used in pulmonary drug delivery, since it
minimizes dose variability.
Being
a global player, we operate in over 100 countries and have our own sales
offices in Germany, the United States, Singapore, Japan and India. The geographical spread of our
production plants enables us to guarantee security of supply, as we offer dual
sourcing to our customers thereby lowering our customers’ supply chain risks.
Our heritage, along with our geographical footprint, allows
us to support accelerated drug product launches so that our customers get the
necessary market advantage.
As patient adherence to drugs continues to be a major challenge, how are you working towards overcoming this? Can you share some of the new developments underway at DFE Pharma? What has been the market response to these developments?
There are various innovations underway to provide better drug
delivery systems to improve patient adherence.
For example, mini-tablets provide an advanced and convenient
drug delivery method which is much easier to administer than conventional
tablets. Mini tablets also overcome obstacles such as impaired swallowing and
polypharmacy (use of multiple medicines) therapy, besides offering therapeutic
benefits such as dose flexibility and combined release patterns.
Mini-tablets can also be formulated as ODMT’s (orally disintegrating mini-tablets). These offer a more
comfortable means to consume unpalatable drugs and many times there is also no
requirement of water, as they dissolve in the mouth. Such tablets are a preferred means of drug
delivery in pediatric and geriatric patients, and certain other targeted
populations.
However, the manufacturing of mini tablets is especially
challenging due to constant die fill in tablet presses that is needed to
achieve constant tablet weight and in-turn achieve good content uniformity.
The efficiency of the die filling process is influenced by
powder properties, such as flowability, cohesion, particle size and morphology,
as well as the process conditions. SuperTab® 40LL is especially designed to produce mini-tablets with good content and blend uniformity. In addition, customers have successfully resolved high dose tableting with superior compact-ability of SuperTab® 40LL.
In view of the increasing precision needed to formulate these
innovative drug delivery systems, how does DFE Pharma assure quality and
consistency?
Since most excipients are powders and the size of the
particles vary, this creates the need for enormous variation in the
manufacturing processes.
DFE offers excipients that operate at the centre of
specifications and are supported by tools like in-house multivariate (MVA) and
principal component analysis (PCA). This, in turn, helps customers in their
Quality by Design (QbD) endeavor.
DFE Pharma provides annual product consistency documents that summarize the production knowledge space, which reflects actual variability/consistency. This approach helps customers understand DFE’s excipient consistency and is a significant upgrade over the usual practice of testing three batch samples or reviewing 10 batch certificates of analysis (COA), which is usually followed by most
customers.
Our approach has been highly commended by customers and
regulatory agencies globally.
What are some of the new initiatives being undertaken at DFE?
With DFE Pharma’s mission to lead in excipient expertise, we are the only excipient company offering two widely used and preferred excipients — lactose and microcrystalline cellulose (MCC).
There have been recent innovations which have been undertaken
in the area of lactose with the introduction of SuperTab® 50 ODT, where all required functionalities are combined into one single high functional excipient with desired pleasant mouthfeel.
In June 2019, we announced the US launch of our excipient eStore. This new e-commerce channel will enable biotech, pharmaceutical and nutraceutical companies to order small quantities of GMP materials, delivered fast to their doorstep.
On our website, we also encourage formulators to post formulation
questions under the ‘Ask an Expert’ section. This service drives one of
our formulation experts to revert with a response within three business days to
drive accelerated drug development for our customers.
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https://www.pharmacompass.com/speak-pharma/our-drug-delivery-system-innovations-seek-to-improve-patient-adherence-speakpharma-with-dfe-pharma
#SpeakPharma with DFE Pharma
03 Oct 2019
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