Medicines formulation

FIGURE 9.4 Analysis of cold medicine formulations containing active ingredients, impurities, and counterions. (Courtesy of Waters Corp.)... 

Note Many cough medicine formulations exhibit the color they have because a food colorant has been added. Such colorants are standard Food, Drug, and Cosmetic (FD8jC) dyes, typically blue 1 red 3, 33, and 40 or yellow 5, 6, and 10. In this experiment, identification of such dyes is accomplished by TLC. 

There are few occasions where a drug is delivered alone in a pure form into the body, but it is usually combined with other materials (called excipients) to form drug delivery systems ( medicines , formulations or dosage forms ). These promote accurate dosing, therapeutic effectiveness, stability and patient acceptability. By far the most common route for delivering drugs into the body is by the oral route, swallowing a tablet or capsule. 

Sadly, practices and laws that should be universal (not all laws should be) do not become so. It is astonishing that following the 1938, FDA-driven outlawing of the use of diethylene glycol in medicinal formulations (see Chapter 6), several countries have reported deaths caused by medicines contaminated with diethylene glycol most recently, 88 children died in Haiti (1995/1996), 33 children died in India (1998), and more than 22 people died in Panama (2006). 

Hydroxyurea (hydroxycarbamide) Nausea and vomicing allergic reactions to tartrazinc dye (c,g. in medicinal formulations) Bone marrow depression stomatitis dysuria alopecia rare neurological disturbances pulmonary infiltrates... 

Cordials Cordials are sweetened alcoholic preparations of high alcoholic content. They are also a tonic medicine formulated to stimulate the heart. 

Name of Disease Herbal Medicinal Formulation No. of Patient Treated (monthly)... 

This problem, which is commonly experienced in the pharmaceutical industry when fine medicinal formulations are to be directly compressed into, for example, tablets (Section 6.2.2), can be overcome by utilizing either a very low densification speed, which may be unprofitable because it reduces the equipment capacity (above), or by keeping the compact for some time (dwell time. Section 6.2.2) at maximum pressure. The latter (curve (2) in Fig. 10.16c) is more often used because it allows fast densification and, overall, a short pressing cycle. When holding the compact for some time at the maximum pressure, additional de-aeration and conversion of elastic deformation occur, resulting in less expansion (s in Fig. 10.16c). Dwell time and re-expansion are interrelated and the optimum must be determined experimentally. Even very short dwell times of a fraction of a second produce surprising improvements. 

Concerning the first therapeutic use, for a known compound which is shown to have a specific therapeutic use, it is possible according to the EPO s practice, to have a broad claim in the form such as substance or composition X for use in medicine . Formulation of claims such as the use of a substance X for the therapeutic treatment of man or animals are not permitted, because they are regarded as methods of medicinal treatment. 

The gold contents in two indigenous medicines, used in India, designated as TMF-14 and TMF-15, have been determined by NAA . Gold has some toxic effects and strict control on standardization of these medicinal formulations is needed, since some shops tend to introduce higher gold contents based on a behef in the miraculous power of gold. 

As well as featuring in soil chemistry and biosystems, sodium cations together with various phosphate anions have many industrial involvements, the most important of which are detergent powders, textile bleaching formulations, metal cleaning compositions, metal surface treatments, water softening compositions, phosphate glasses, dietary supplements and medicinal formulations. 

Administration devices for medicines used to treat asthma and COPD are prescriptirm products, with an exception for some nebulised (medicine) formulations. Medicines such as amphotericin B or antibiotics (coUstimethate sodium, tobramycin sulphate or gentamicin) for nebulisation in CF therapy are sometimes stUl partly prepared by hospital pharmacists, and so are nebulised solutions for bronchial challenge testing. Although product formulation and the method of preparation of formulations for inhalation are not the main subjects of this chapter, recommendations are given in the subparagraphs about nebulisation. 

In contrast to DPIs the basic design of MDI hardware is well described in the literature [23, 24]. Most MDIs apparently have a simpler design than DPIs and a key advantage of MDI systems is their low cost per dose. They are portable, convenient and have widespread acceptance by patients and clinicians. Basically they all have the same operational principle and furthermore all MDIs deliver a constant fine particle dose (independent of the flow rate). Whereas they have a relatively low resistance to airflow and this all makes the inhalation instruction less dependent oti the individual type of MDI. The most relevant differences between types are in the actuator design and medicine formulation (solution or suspension), in which the type of propellant and the presence of co-solvents play an important role because of their influence on the (plume) velocity with which the aerosol is released from the actuator and rate of droplet evaporation. 

A great variety of jet and ultrasonic nebulisers is available for a wide range of size distributions and different output rates [45]. If an inhaler is approved for the administration of a particular type of medicine formulation, it should be the first choice for that application. If the nebuliser or compressor (for jet nebulisers) is not available, as for instance... 

Most product information leaflets for nebulised medicine formulations discourage mixing of marketed formulations but in practice different formulations are frequently mixed to increase patient comfort. Particularly CF patients tend to combine medicines in order to save time as well as to overcome adverse effects (e.g. bronchoconstriction) of one active substance (antibiotic) by another (salbutamol). They also tend to refill their nebuliser with a new medicine without emptying and cleaning the nebuliser between the administrations. Relatively little has been reported in the literature about the compatibility of medicine mixtures, however, and interactions may be expected with respect to chemical and physical stability, droplet size distribution of the aerosol, nebuliser output rate and therapeutic effect. From a survey of studies on chemical stability, it is known that particularly domase alpha (Pulmozyme ) is incompatible with many other nebulised medicine formulations due to inactivation of the protein [63]. Additives, like stabilisers that work well in some medicine formulations, may be incompatible with other preparations and induce cloudiness... 

Mary NK, Babu BH, Padikkala J (2003) Antiatherogenic effect of Caps HT2, a herbal ayurvedic medicine formulation. Phytomedicine 10 474-482... 

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