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What is Portland Cement?
Portland cement (PC) is the principal binder that, upon hydration and setting, holds aggregates (coarse and fin

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

e) together in concrete. It has the ability to stand in water and increase its strength over time. This ability elicits the term hydraulic cement f

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

or this type of cement.

What is the Composition of PC?
PC is a manufactured product formed within narrow confines of specific elements a

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

nd subjected to heat treatment to form a semi-finished product called clinker. Raw materials used include: Limestone, Shale, Iron Ore and Sand.

The

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

principal elemental ingredients in the raw materials are:
• Calcium Oxide (CaO)
• Silicon (SiO2)
• Aluminum Oxide (Al2O3)
• I

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ron Oxide (Fe2O3) in addition to other elemental oxides.

It is possible sometimes to have all these elemental oxides in some limestones. Where

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

the principal source, limestone, is deficient in any of the elemental oxides then the other ingredients are added in the right proportion in preparat

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ion for the manufacturing process.

The latter process comprise of three phases:
1. Grinding the materials into a powder form
2. Heating th

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

e powdered material in a kiln up to about 2700°F
3. Grinding the clinker formed with gypsum to form PC

When PC is mixed with water either

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

to form a cement paste or concrete, in a process called hydration, a chemical reaction takes place and for simplicity sake two principal products are

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

formed: 1) calcium silicate hydrate, C-S-H and 2) calcium hydroxide

Calcium Silicate Hydrate (C-S-H) is insoluble in water. It gives the title hydr

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

aulic to set PC’s ability to stand in water without any detriment. Calcium hydroxide is soluble in water and leaches out of set concrete and in a tw

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

o step approach first, the solution is drawn to the exterior wall of the structure and secondly, react with carbon dioxide of the atmosphere to form

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

chalk, the white, efflorescence salt found on concrete walls.

MINERAL ADMIXTURE - Mineral admixtures used in concrete formulations contain o

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

xides of silica and other oxides that are found in Portland cement. Examples of mineral admixtures include fly ash, silica fume and volcanic ash.

M

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ineral admixtures used in concrete may be referred to as Pozzolans, or materials that won’t harden in water but in the presence of lime, react and

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

harden to form a stone-like mass.

One important use of mineral admixtures in concrete is the ability of the silica component to react with the solub

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

le calcium hydroxide formed in the hydrating cement to form an insoluble calcium silicate hydrate thus helping to form a dense, compact concrete/ceme

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

nt paste.

Concrete formulated with mineral admixtures are not likely to form efflorescence salts. The use of mineral admixtures in concrete helps re

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

sist sulfate attack and alkali-silica reactivity. In the fresh concrete the presence of mineral admixtures often improve the workability of the mix.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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