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To mix cement plaster, the cement, with or without 10% of lime, should be mixed thoroughly with sand until the colour is uniform. The water is then added gradually while mixing continues and until the required consistency

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

is obtained or until it is just plastic enough to be spread and to hold to the building wall. It must be used within 45 minutes of mixing and no plaster that has begun to set should be remixed with water and used.

To mi

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

Examples of combination products may in

x cement-lime plaster, the cement, lime and sand may be mixed dry in the required proportions, then mixed wet with sufficient water to give the required consistency. With this method, the plaster must be used within 45 mi

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

utes of mixing and no re-tempering of partly set plaster should be attempted. More often, the lime and sand are mixed together first, to form what is known as the 'coarse stuff', this allows for further hydration of the l

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

ime before using and makes it easier to apply, more plastic and quicker setting. With this method mix 1 part of lime with 6 or 41/2 parts of sand (depending upon whether the mix is to be 1:1:6 or 1:2:9), first dry and the

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

Combination pro

with sufficient water to give a stiff mix, adding the water gradually. The mortar should then be formed into a heap, covered with wet sacks and left for a week to 10 days. Then, immediately before use, the coarse stuff

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

should be mixed with cement, using 1 part cement to 6 or 9 parts of coarse stuff, adding water if necessary to bring to a workable consistency, just right for plastering a building. After the cement is added the mortar mu

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

t be used up within 45 minutes and no re-tempering of partly set mortar should be attempted.

To mix lime plaster, mix 1 part of lime with 3 or 4 parts sand, first dry and then with sufficient water to make a stiff mix. H

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

eap, cover over and keep damp and allow it to mature for 7 to 10 days. Then work up again, adding water if necessary and it is ready to use. Lime mortar, if kept damp may stand for 3 or 4 weeks before using. Sometimes,

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

p to 10% of cement is added to the coarse stuff to quicken the setting, in which case the mortar must be used up within 45 minutes of mixing.

Another method applicable to either cement plaster or cement-lime plaster is to

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

mix the lime with water to a thick cream and allow to stand for 24 hours to seven days before mixing with the sand.

The building surface to be plastered must be cleaned free from paint, oil, dust, dirt, etc. As it is di

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

Following aspects would a

fficult to make plaster adhere to a very smooth surface, it is advisable on brick and block building walls to rake out the joints about ? in. to provide a mechanical key, or to strike off the joints roughly with the face o

dd to the challenges in developing combination products:

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

the building wall relying on the roughness to form a key. Joints should be raked while the mortar is still soft.

Dense concrete blocks should have a rough surface, which is best obtained by wire brushing while they are

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

still 'green' and the moulds should be treated with whitewash instead of oil. Dense in-situ concrete should also be wire brushed while still 'green', since, if allowed to harden, the surface will probably be so smooth tha

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

it will have to be hacked to provide a satisfactory bond for the building plaster.

If a key is not formed by roughening or hacking the surface of dense concrete, either cast-in-situ or in blocks, a 'spatter-dash' coat of

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

mortar should be applied. This consists of a mix 1 part cement to 1 ? parts of coarse sand first mixed dry and then with sufficient water to give a fairly wet mix. This is dashed onto the building wall in an uneven mann

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

Professional from academic institutions, pharmaceutical industries, health care indust

r, usually with a coarse brush, using a strong whipping motion at right angles to the face of the building wall. This coat should be kept damp for at least two days and then allowed to dry out.

New brick and concrete wal

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

ls should be allowed a reasonable time to dry out before plastering. When the wall has been prepared by cleaning, raking joints, roughening or given a 'splatter-dash' coat, it is ready for plastering.

If the building wal

.

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

is irregular and out of plumb and it is desired to have the finish plaster surface a true plane, it is necessary to 'make up' or 'dub out' the low spots by successive making-up coats, each about 3/8 in. thick. These shou

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

Companies that provide selfless information through particip

ld not be carried to a 'feather-edge' but should stop back forming a ledge about 1/8 in. thick. When the making-up coats have brought the building wall to a reasonable plane surface the actual plaster coats can be applied

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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