What Is an Excipient?

An excipient is a non-active pharmaceutical substance that serves to streamline the manufacture of a drug formulation and facilitate physiological absorption. It is characterized by its consistency of composition, from lot to lot and conformance to the official monographs or specifications.

Using a supplier who manufactures the excipient on dedicated equipment reduces the likelihood of cross-contamination from other materials and processes. This is especially important as the supply chain from the excipient manufacturer to the pharmaceutical manufacturing facility contains multiple opportunities for contamination or tampering.

Biocompatibility

Due to their structural similarity with teeth and bones, calcium phosphates have great biocompatibility with human body fluids and tissues. They are also non-toxic. Therefore, they are widely used in dentistry as bone cements or tooth substitutes [1, 2]. In addition, hydroxyapatite promotes the proliferation of osteoprecursor cells, such as stromal stem cells and osteocytes, accelerating the formation of new bone tissue. Foppiano et al. evaluated the in vitro biocompatibility of functionally graded titanium/hydroxyapatite bioactive coatings with Ti-6Al-4V alloy by using mouse osteoblast-like cells. They found that the functionally graded material performed better than Ti-6Al-4V alone and tissue culture polystyrene.

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Targeted Drug Delivery

The goal of targeted drug delivery is to increase the concentration of drugs in diseased tissues by reducing their distribution in healthy tissues. This goal can be accomplished using a number of different strategies. These include active targeting, bionanotechnology strategies, and exogenous physical triggering. Targeted drug delivery can also help improve the effectiveness of existing medications.

A key challenge is delivering drugs into the brain without crossing the blood–brain barrier. The BBB is a microvascular network composed of pericytes, astrocytes, and endothelial cells that separates the central nervous system from the blood circulation. It is essential for maintaining normal neurological function and homeostasis, but it can prevent the delivery of many drugs needed to treat neurodegenerative diseases.

To overcome this challenge, researchers are developing a range of nanoparticle-based systems for tissue-selective delivery. These systems can be delivered by intravenous, oral, and topical administration. In addition, they can be triggered by ultrasound (US), which can induce local tissue heating or cavitation to enhance the delivery of nanoparticles to diseased tissues. These targeted drug delivery systems can be used to deliver a wide range of therapeutic agents, including small-molecule drugs, antibodies, and stem cell therapies. The key to these systems is that they use a targeting ligand that has low affinity for healthy tissues and high affinity for pathologic tissues.

Safety

Excipients are generally considered safe, since they have been used in the food industry for a long time. They are also often compendial substances (monographs in the United States Pharmacopeia, European Pharmacopeia, or Japanese Pharmacopeia) or are widely used in the pharmaceutical industry, and they usually have physicochemical properties that guarantee their suitability for use in a drug formulation. However, a 100% excipient-free drug formulation is not possible due to issues such as drug solubility, dispersibility and targeting. In order to ensure that the physicochemical and biopharmaceutical characteristics of the final dosage form are guaranteed, it is necessary to test for functionality-related characteristics (FRC) of the excipient.

FRC tests, such as apparent viscosity and degree of substitution, are not mandatory but improve knowledge about the quality attributes of a specific excipient. However, the test data does not always directly correlate to how an excipient performs in the drug formulation process. This is because an excipient typically consists of a mixture of substances that may have unavoidable constituents, such as residual processing aids, additives or by-products, and can also include contaminants such as rust, oil, grease, insect fragments, extractable and leachable material.

The quality of an excipient is best characterized as compliance with the applicable GMPs and the specification or monograph, including a consistent composition profile lot-to-lot and within the lot. The manufacturer must use clean equipment or water that does not contact the excipient during manufacture and has adequate cleaning validation.

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