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As of today we have 76,, eBooks for you to download for free. No annoying ads, no Handbook of Pharmaceutical Manufacturing Formulations. Purchase An Introduction to Pharmaceutical Formulation - 1st Edition. Print Book & E-Book. eBook ISBN: Imprint: Pergamon. Published. Formulations Moreover the Lord spoke unto Moses, saying: Take thou also unto thee Download PDF Pharmaceutical formulations.

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Pharma eBooks. 0 Each entry begins with a fully validated scaleable manufacturing formula and a Download at: or Buy eBook. Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic. Pharmacy is a diverse field, of which pharmaceutics constitutes an integral part. This book has been designed to sensitize the students of pharmacy to the core.

The sixth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers the sterile products, which include formulations of injections, ophthalmic products and other products labeled as sterile, from publicly available but widely dispersed information from FDA New Drug Applications NDA , patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing sterile products, the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics inspection of sterile products manufacturing facilities, new drug application for sterilized products, in addition to providing quick tips on resolving the common problems in formulating sterile products as well as the scope of details included in the series for all dosage forms. Download at: You must be logged in to post a comment. Handbook of Pharmaceutical Manufactur

Should we wish to change the active ingredient, we may well find ourselves in a position where we must change the entire formula. This is further complicated when we determine the appropriate protective agent e. Not only does the number of possibilities increase at this stage, but most of the time we cannot rely on theoretical considerations for making the choice. Formulation development needs a clear goal.

For a particular polish we may find that the more shine it produces, the more difficult it is to apply. And the manufacturer must evaluate the consumer's preference: But mainly, problems of undesirable interactions between components are avoided, thus limiting unforeseen complications. This approach which is related to the formulation of medical preparations is also supported by formulators of cleaning agents [5], and should be considered as a general recommendation.

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The everlasting struggle for better products exists in the field of formulations too. While in developing an industrial process we aim for high yield, output and quality, in developing a formulation we wish that the product will "do its job" in compliance with our predetermined definition.

In the case of the car polish mentioned before, we test continuously during its development for the following product characteristics [4]: Formulations 39 And what do we test for in the development of hair conditioners [7]? In dealing with formulations, we have at our disposal several sources of information: We just have to bear in mind that the information might be incomplete and, as mentioned earlier, if we change one component in our composition, we may have to go back to the laboratory and start from scratch.

In such cases, the amounts of the different ingredients are not detailed. This usually involves infringement of the proprietary 40 Chapter 3 rights of the original formulator — rights which are protected either by tradenames see Chapter 1 or by patents see Chapter Mother Nature, supported by creative formulation chemists, makes it quite difficult for imitators to analyze a formulation, and the cost of such an effort cannot be overlooked.

A case is described [11] where, for patent infringement investigation, an analysis was done on a reactive dye formulation.

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After two years, only the chemical classes of the components could be specified. But that is far from being accurate. The main exception is the formation of wastes: The yield on each ingredient is one hundred percent, and there are no side reactions — hence wastes are caused only by spillage, or by dumping rejected batches.

The formulator is indeed less troubled by the problem of wastes than his colleague who deals with chemical processing. As for safety considerations see Chapter 11 , the formulator needs not worry about runaway reactions. Since formulations find their way to the final consumer, toxicity problems are limited. But other safety aspects are as important as in other chemical activities.

This applies mainly to flammability and mechanical equipment. Specifications for a formulation seem to be less strict than in producing a composition chemical, since the formulation is marketed by its performance rather than its specifications see Chapter 5.

This is a false impression, at least for high-quality formulations. Deviation from the required composition, pH, viscosity, color, etc. Nash [2] recounts the case of failure in a steroid ointment when transferred from one production site in the United States to another, in India. The product was not stable and suffered from "weeping" the bleeding of clear liquid oil from the ointment. It was finally concluded that the cause of the problem was the specification of a particular raw material, which was a formulation in itself.

The material in question was Petrolatum U.

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Problems of construction materials must also be addressed in the field of formulations see Chapter 7. However, they are less complicated than in chemical processes. Since formulations are used by the final consumer, their corrosiveness should be nil to moderate. Construction materials for pipes, seals, etc. Another aspect which seems to be irrelevant to the formulations' production is scaling-up. Since mixing operations, rather than chemical reactions, are the heart of this industry, one may assume that the scaling-up is simple.

The discussion of that point in Chapter 8 shows that this impression is wrong, and the developer of a formulation must carefully upscale his process to ensure a smooth running-in at the production plant. What is then required of motor oil? In fact, there are two basic requirements: Oil possessing suitable viscosity seems to meet these requirements.

Mineral oil is usually a complex mixture of many organic materials, mostly saturated, unsaturated and aromatic hydrocarbons. In addition, basic mineral oil contains oxygen, nitrogen and sulfur compounds.

Such a composition characterizes, in fact, all petroleum fractions. The sources for petroleum in different parts of the world yield a variety of qualities and compositions. Therefore, when straight mineral oils were used as such for engine lubrication, their distillates also varied in quality. The criteria for a good lubricating oil were as follows: Thus, the higher the degree of saturation of the oil, the greater its stability. It is known that the viscosity of oil decreases as temperatures rise.

This is undesirable, since "thin oil" possesses lower lubricating power. Throughout the years, the car industry demanded better and better lubricating oils, and the oils became more and more complex. In , the market for motor oil additives was estimated at 3 billion dollars, with a forecast for 4 billion dollars [12]. Worldwide production is divided among about 7 manufacturers — a low figure which is undoubtedly due to the high cost of authorizing a new package of additives — above one million dollars!

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How did this development of motor oil formulation come about? Lubricating oil functions in a very "hostile" environment — high temperatures, high shear forces, chemical attack by oxidation and by Formulations 43 Wear Sludge Figure 3. Marsh, Chem. London , [13]. The acidic materials may be carboxylic acids from oxidation of hydrocarbons or, for example, sulfuric acid from sulfur oxidation in sulfur-rich fuel. The oxidation increases the viscosity, preventing the oil from flowing to the required engine parts; the degradation products cause corrosion and wear of the engine; the polymers concentrate and adhere to the moving parts pistons thus hindering their performance.

In addition, wear of the metal parts forms metal particles, as well as inorganic salts, all having limited solubility in the oil; these particles are also collected on the moving parts, causing reduced sealing between the pistons and the cylinders. Water, which is formed when the fuel is burned, increases corrosion and tends to accumulate in low places as a separate phase.

Soot is also formed, adding to the overall sludge. Dust penetrates the air filter and settles. And residual, unburned fuel thins the oil. Another difficulty encountered in the use of mineral oil is that we "go against Mother Nature". Oil is thick when cold and becomes thinner at higher temperatures. And here we come along, demanding that oil 44 Chapter 3 be thin at low temperatures so that we can easily start the engine , and thick at high temperatures when effective lubrication is essential.

All of these problems have to be solved, and we claim that the solution lies in the use of additives. Most modern motor oils contain the following basic additives: Pour point depressants. Metal deactivators. On the one hand, interacting with the oil, they act as antioxidants and anticorrosion agents. On the other, interacting with the metals, they prevent wear, as they form thin protective layers on the metal surface. These layers contain zinc polyphosphate, iron sulfate or polymers of zinc, phosphorus and sulfur.

Detergent-Dispersants — The role of these additives is to disperse all the oil's impurities soot, dust, salts, acids, polymerization products, water and to prevent them from accumulating and settling on sensitive parts of the engine. Therefore, effective dispersion causes a cleansing action and waste removal when the oil is replaced.

Thus, if the oil being replaced is very black, it is a positive indication that the cleansing is effective. If the used oil is light in color, it indicates that the sludge has remained in the engine. Formulations 45 These compounds contain a lipophilic skeleton attached to a hydrophilic end. This structure characterizes detergents Chapter 4 , and hence the dispersing and cleaning properties of these additives.

The lipophilic part of the molecule causes the sulfonates to dissolve in the oil, even though they are ionic salts. These salts are not expected to dissolve in water — but in oil?!!. The purpose of this special effort is to produce an additive with excess alkalinity which neutralizes the acidity created in the oil. These additives are thus called "overbased sulfonates".

Viscosity Index Improvers — The viscosity index VI indicates the extent of viscosity reduction as the temperature rises the smaller the change in viscosity, the higher the index. The VI improvers are solving the problem of "going against nature": This is achieved by the use of polymers polymethacrylates or polyisobutylenes for which the oil is a poor solvent.

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At room temperature the molecules of these polymers disperse as random coils. As the temperature rises, the coils open and the polymer molecules stretch to an elongated form, thus raising viscosity, and offsetting the natural decrease in viscosity caused by heating the oil. The oils containing VI improvers are called multigrade oils, and can be identified by the numbers indicating their viscosity, e.

This means that the basic, straight oil is SAE 20 thin! The W stands for Winter, when this is most important. And so, aided by the basic oil and the three main additives, we have a product which lubricates, prevents oxidation, prevents wear, neutralizes acidity thus preventing corrosion, cleans the engine and provides suitable viscosity at all temperature conditions [14].

Washing Powder The features required of a good washing powder are many, and the requirements are generally met by the use of additives. This highly competitive market tempts irresponsible manufacturers to offer lowpriced products at the expense of quality. The temptation to neglect one Chapter 3 46 aspect or another by eliminating additives and thereby reducing its cost is not surprising.

Clearly, washing powder's primary component is the "soap", a surfactant responsible for wetting the fabric and cleaning the soil. As we know, tap water contains calcium and magnesium salts which, depending on their amounts, determine the water "hardness". With certain surfactants, these materials form calcium and magnesium salts which are water insoluble.

Therefore the active ingredient content is reduced, causing its activity to decrease. This compound must be soluble so that it will not be deposited on the cloth but rather wash out in the rinse, and stable so that it will not break down by heat and alkalinity and again permit "contact" between the calcium or magnesium and the surfactant. The use of condensed phosphates polyphosphates is common, e.

This creates stable compositions: The condensed phosphates have the disadvantages of instability in heat and in basic conditions which characterize the laundering process and break down to calcium phosphate, Ca3 P04 2, which is insoluble and therefore undesirable.

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Higher grade washing powders therefore contain organic materials which are "better at the job", but naturally higher priced. These materials are called chelating agents. An example is ethylenediamine tetraacetic acid EDTA which creates very stable chelates with calcium and magnesium. Another additive is required to prevent this. The most common one is polymeric: This charged polymer adheres to the cleaned cloth giving it a high negative charge.

The dirt particles dispersed in the solution are also negatively charged, and thus they are rejected by the cloth and will not redeposit. Formulations 47 Surfactants are poor stain removers. Therefore, the formula has to include bleaches, the best of which contain active chlorine. However, because of their high reactivity they may damage the cloth.

The use of chlorine is forbidden in Europe. Another common bleach is sodium perborate NaBOs , which releases hydrogen peroxide the actual bleaching agent. An additional common and similar bleach is sodium percarbonate. In order to solve the problem of biological stains, enzymes were developed proteases, amylases which act specifically on the biological components of the stains.

These enzymes are not bleaches in the usual sense, but rather break up the tissue causing the stain, thus allowing the regular detergent to take over. This presents an example of a formulation in which the various components counteract each other: The "art of formulation" is to find the optimal balance between the contradicting requirements.

Some of us may remember "laundry bluers" used years ago, long before washing machines were available. The tendency of the fabric to yellow with age was overcome by a "bluer", added to the laundry rinse in small amounts, making the yellow tint invisible. Today we do not use "bluers" but rather optical brighteners. These are complex organic chemicals possessing fluorescent properties, which absorb ultraviolet energy and emit blueviolet radiation.

Here, too, the yellowish tint is "blurred" by the blue tint and the cloth appears to be white.

The chemist developing washing powders has another problem to consider as well — possible corrosion of metal zippers, metal buttons and, of course, the washing machine itself. Corrosion is a natural phenomenon in an atmosphere of boiling water, vapors and various chemicals. It covers the metal with a very thin protective coating. As a "fringe benefit", it prevents the sedimentation of calcium and magnesium salts. Have you ever encountered "lumps" in washing powder?

Often the result of overlong storage, these lumps present a double problem: They dissolve with difficulty, and they settle on the cloth. To prevent the formation of lumps a disturbing process which is called caking , a bit of sodium sulfate Na2S04 is added to the powder.

Today, we want soft clothing, pleasant to touch, and a good washing powder should therefore contain softeners. Softening agents molecules consist of hydrocarbon chains as in soap with a cationic end unlike soaps where the end of the molecule is negatively charged.

During the laundering, the cloth is charged negatively. Examples of typical softeners are: Baking Powder and Leavening Agents The process for leavening baked products by releasing C O 2 was already developed in the 19th century.

It was naturally assumed that the best approach was to make use of the thermal decomposition of sodium bicarbonate: Easily read eBooks on smart phones, computers, or any eBook readers, including Kindle.

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Institutional Subscription. Free Shipping Free global shipping No minimum order. Foreword 1. Background 2. Diluents, Solvents and Liquid Vehicles 3. Thickeners and Binders; Fats and Waxes 4. Surface-active Agents 5. Colors, Flavors and Preservatives 6. Solid Formulations 7. Liquid Formulations 8. Paste Formulations 9. The Control of Drug Release Stability Containers Process Establishment Index.

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