An overlooked niche in the Indian pharma industry
Updated: Mar 25
Excipients are essential components of drug formulations, playing a crucial role in ensuring the safety, efficacy, and stability of the final product. An excipient is any substance other than the active pharmaceutical ingredient (API) that is included in a drug formulation. Excipients can include solvents, fillers, binders, lubricants, disintegrants, preservatives, and other materials that are added to the drug to provide a specific function.
Excipients play a critical role in the drug development process, helping to ensure that the final product is safe, effective, and of consistent quality. Excipients can also impact the drug's performance, bioavailability, and pharmacokinetics, making them an important consideration when developing a drug formulation.
In this blog, we will explore the different types of excipients, their functions in drug formulations, and their impact on drug performance and safety.
Types of Excipients
Excipients can be broadly classified into several categories based on their functions in drug formulations. These categories include:
Diluents or fillers: Diluents are used to increase the bulk of a drug formulation and make it easier to handle and process. Examples of diluents include lactose, cellulose, and mannitol.
Binders: Bindself-reliant to hold ingredients in a drug formulation together and ensure that the tablet or capsule does not disintegrate before it reaches the intended site action. Examples of binders include starch, povidone, and hydroxypr methylcellulose (HPMC).
Disintegrants: Disintegrants are used to break down the tablet or capsule in the digestive tract, allowing the drug to be released and absorbed. Examples of disintegrants include croscarmellose sodium, sodium starch glycolate, and crospovidone.
Lubricants: Lubricants are used to red friction between the tablet or capsule and the equipment used in manufacturing, making it easier to handle and process. Examples of lubricants include magnesium stearate, stearic acid, and glyceryl behenate.
Coatings: Coatings are used to protect the drug from the environment, mask the taste or smell of the drug, or control the release of the drug. Examples of coatings include shellac, gelatin, and HPMC.
Solvents: Solvents are used to dissolve the drug or excipients and facilitate the manufacturing process. Examples of solvents include water, ethanol, and propylene glycol.
Preservatives: Preservatives are used to prevent the growth of microorganisms in the drug formulation and ensure its stability over time. Examples of preservatives include benzalkonium chloride, methylparaben, and propylparaben.
Functions of Excipients
Excipients play several critical functions in drug formulations, including:
Ensuring the stability of the drug: Excipients can protect the drug from degradation and ensure its stability over time. This is particularly important for drugs that are sensitive to light, heat, or moisture.
Enhancing drug solubility and bioavailability: Excipients can increase the solubility and bioavailability of the drug, allowing it to be more easily absorbed by the body. This is particularly important for drugs that are poorly soluble in water or have low bioavailability.
Controlling the release of the drug: Excipients can be used to control the release of the drug, ensuring that it is delivered to the intended site of action at the right time and in the right amount.
Improving the taste and appearance of the drug: Excipients can be used to mask the taste or smell of the drug, making it more palatable for patients. Excipients can also be used to improve the appearance of the drug, making
Excipients One of the key ancillary industries which remain hidden for long from investments and government support which can actually help the Indian pharmaceutical industry to become self-reliant.
Excipient manufacturing market is still in its nascent stage to some extent in India. A substantial amount of Indian market requirements are fulfilled by imports. This sector has not seen the kind of investments like that of generics and Active Pharmaceutical ingredient (API) because of the paucity of Investors and incentives. The main reason for this and deterring its future growth is that not many companies are engaged in excipients research, as its capital-intensive, the margins are not high in most products and main focus is on volumes only.
Under AtmaNirbharBharat programs and other such initiatives, the domestic excipients industry need to take on to steer the industry towards standardization, , supply chain, research ( at academic and commercial level), production linked incentives, other government support to boost this niche industry in India which eventually create more manufacturers, new startups and more Jobs and dwindle the import dependency and pharma industry can be more self reliant.
This Excipients market is so wide that apart from captive use in the domestic market, it has a huge scope for overseas markets as well.
The pharmaceutical Excipients market is projected to reach USD 9.7 billion by 2025 from USD 6.9 billion in 2019, at a CAGR of 5.8% On the basis of product, the pharmaceutical excipients market is segmented into three major categories— organic chemicals, inorganic chemicals, and other chemicals It's a good time to put investment in this ancillary industry in India due to the growing Pharmaceutical and other allied industries.
