One of the most crucial elements required for formulating drug products is “Excipients”. They not only deliver up to 80% of drug formulation but are also effective. To date, there is no individual way to approve novel excipients. Almost every excipient used in formulating drugs is enlisted in FDA’S IID (Food and Drug Administration’s Inactive Ingredient Database). However, some have been in use for years while others have recently developed, including Noval excipients. As a result, novel excipients were developed.
The compound that is not enlisted in IID or the ones enlisted but are determined to be used at a higher level of dosage or in a complex way, then this type of compound is termed as “Novel Excipients”. These compounds can be co-processed, combined, and developed physically via Engineering Particles and come in unique packaging termed as “GMP packaging”.
New Challenges require new solutions.
Since there is no individual authorized pathway for every kind of novel excipients. Due to which enormous challenges arise for drug formulators. Recently, there have been huge advances in understanding biological diseases and developing astonishing treatments for deadly diseases. Due to poor physical/ chemical properties, a lot of volunteers suffer from enormous problems.
In the case of Oral drug volunteers, excipients tend to face enormous challenges related to low or poor solubility or permeability. It is essential to have at least aqueous solubility as it helps in imitating drug development for undeveloped volunteers.
In the case of “Parenteral delivery”, excipients are derived from the growth occurring in macromolecules. These are essential for enhancing solubility, chemical stability, and physical stability among excipients while reducing viscosity.
As per scientists, the pain occurred after injecting parental medicines, the taste changes among pediatric patients, and various manufacturing issues can obstruct the development procedure of new and enhanced formulated drugs. Usually, these challenges occur during therapeutic modalities, administration routes, and different dosages. Novel excipients or developed excipients tend to provide scientists with advanced or much-needed tools to consider these challenges.
There are enormous usages of Novel dosage. The industry is evolving around multiple dosages and delivery methods in today’s world, including transdermal, mucoadhesive, and targeted immunotherapies. Especially those situations which require specific solutions and acceptance of novel excipients.
In today’s world, drugs have been presented among various formulation challenges alongside those excipients used for around 100 years. These excipients don’t tend to resolve issues anymore, nor do they allow optimization of new and improved manufacturing methods, including 3D printing.
Novel excipients provide a means for designing functionality so that it addresses ascertained problems and challenges that drug dealers face in day-to-day life. Yet some needs cannot be accomplished at any cost.
How to prevent the risks involved in using novel excipients
The approval of Novel excipients is knotted with almost every new drug that already comes with an attached risk. Adding an unapproved excipient will not only reduce that additional risk but will also pursue a last resort.
Perhaps, adding a new drug product approval to a novel excipient approval will only double the risk among regulatory approval. Whilst simultaneously, enhance the cost of development. The worst possible situation is the failure of anyone will lead to the loss among the investments done on both.
The International Pharmaceutical Excipients Council (IPEC) of America has strictly instructed the drug developers to use only those excipients that FDA has enlisted in IID. Though, these statements can sometimes discourage pharmaceutical companies from investing their time and efforts in novel excipients.
Drug developers suggest using novel excipients formulating drugs, especially those that can be developed without enhancing the quality or improving performance. In some cases, an individual approval process can opt when the additional risk is outweighed. The excipient manufacturers do not have any incentive to develop new products as they don’t have a return for at least a period of 15 to 20 years.
These risks can sometimes be perceived as having additional supporting data that has more toxicity than the previously approved excipients available already. The lack of an established pathway will lead to uncertain problems.
The FDA’s silence on this particular issue, lack of specified policy for it while the risk of landing the special novel excipients in the hands of a new drug applicator while they don’t understand how to use these types of assessment, in reality, may lead to fails and loss. As a result, a huge risk involves novel excipients.
Awareness of these issues is simultaneously related to the limited safety of novel excipients. This may not be surprising as there is no guidance at all. The considerations related to innovation/ assessment cannot be expected as the positive impact of novel excipients will always be a part of the drug regulatory review process. Perhaps, the most crucial element for novel excipients is to have an independent safety review process.
Final words
In the long run, there is a hope that with the help of novel excipients and Nicheexcipients, there will be global consistency at some level, or it can be achieved after the approval of novel excipients. As a result, it will benefit the biopharmaceutical industry and help develop pilot programs, especially for patients.
