Excipient is accelerating pharmaceutical formulation technologies and novel drug delivery system development consequently boosting the development of excipient industry. Indian pharmaceutical industry has rapidly narrowed the gap between world leading edge companies with innovative formulation R&D and its application
Excipients are usually defined as the non-active ingredients that are mixed with pharmacologically active compounds to form medicines, particularly tablets. The behavior and effectiveness of many drugs are governed in part by excipients.
Some ingredients are used to ensure that a preparation has great crushability and therefore is easy to manufacture in tablet and capsule forms. Others give tablets a sweet taste. Still other excipients may ensure slow release of the drug or provide great compressibility so that a pill can be made smaller.
There are excipients with specific roles in the delivery matrix of formulations and there are excipients which mainly perform the role of binder or fillers or lubricants. In this category you have sugar, lactose, starch, cellulose, mangnesium state etc, all time tested excipients.
The need for pure quality excipients is a must but it also important is that these excipients perform the limited but important role assigned to them of making a good tablet. It is here that the pharmacopoeia standards very often fall short. The pharmacopoeia standards give requisite importance to the chemical purity but fail to set standards for the physical parameters which are critical especially in direct compression on high speed tableting machines.
Flow ability, particle size distribution, bulk density, tapped to untapped bulk density, compressive strength, loss on drying and colour are all parameters which need to quantified and tested to ensure a good sturdy formulation. A high quality excipient would ensure that the high cost API’s are not compromised during the formulation stage. The need for good manufacturing facilities for excipients with proper accreditations is the need of the hour.
Excipients also can improve a drug's general efficacy, safety, stability, and storage. The main categories of excipients include:
- suspending or dispersing agents;
- film formers and coatings;
- printing inks.
World Health Organization (WHO) has laid down guidelines for excipient manufacturers in Essential Drugs & Medicine policy. The guidelines covers equipments( use of equipment, cleaning programme & procedure, sampling plan and analytical methods), materials(starting materials, Rejected & recovered materials and Storage practices), documentation(Specifications and Batch production records) and good practices in production & quality control (Change control & process validation, Good practices in production, prevention of cross contamination and in process blending, control of microbial contamination, packaging operation and delivery, quality records, stability studies & revaluation dating).
India and China have entered the excipients market and have become formidable forces in the production of active pharmaceutical ingredients (APIs).
The total pharmaceutical excipients market in India is expected to grow to to etimated revenues of $1.39 billion in 2008 from revenue worth $1.13 billion in 2004. The market is growing at a compound annual growth rate (CAGR) of 5.3%
While Europe and North America currently contribute to approximately 75 percent of the global excipients market – with Europe accounting for about half of this share – the entry of manufacturers with substantial cost advantages is posing a challenge to European pharmaceutical excipients manufacturers.
India has advantage of low-cost manufacturing capabilities without compromising on product quality. India also has a strong presence in active pharmaceutical ingredients (APIs) and intermediates manufacturing and has built up a good brand image.
Excipients, particularly bulk excipients such as microcrystalline cellulose and lactose, face the problem of continuous commoditisation. This has created a situation of increased price pressure and shrinking profitability, with even speciality products likely to be at risk. Commodisation is primarily caused by manufacturers that are always looking for opportunities to reduce their expenses. Manufacturers from low-cost countries entering the market are another contributory factor.
Pharmaceutical and Allied Manufacturers and Distributors Association (PAMDAL), has established an excipent chapter.
- Pharmaceutical coating Pvt ltd
- Ideal Cures Pvt ltd
- Signet Chemical Corporation
- Gangwal Chemicals
- SA Pharmachem
- Panoli Intermediates India Pvt. Ltd