Ranitidine hcl pdf




















Much work1,2 on R-HCl Structure: highlights its usefulness. The formulation and in vitro 3 evaluation of drug has been done by Dave et al. The optimization of formulation of different types of fillers,viscosity grades and concentration has revealed that these parameters have significant effect on release of Chemical name: drugs from hydrophilic matrix tablets and floating N[2-[[[-[dimethylamino] n-methyl]furanyl] methyl] properties5.

Investigation on method polymer co-relates it thio]-n-methylnitro-1,1-ethenediamine HCl. RM Franc,7 R. Kaza et al. R-HCl contains not less than While to pale yellow, crystalline powder Design, evaluation and study of effect of hydrophilic Solubility : polymers on release rate of antiulcer floating tablets was Freely soluble in acetic acid and water, soluble in methanol.

Sparingly soluble in ethanol, practically studied by BV Akbari et al 9. Preparation and evaluation insoluble in chloroform. Research work on drugs and polymers with calculated on the dried basis, do not differ by more than faithful results was carried out by RJPDFT11 3. The molecular weight ranitidine daily, in divided doses, by intramuscular or of hypromellose ranges from to Various slow intravenous injection, the equivalent of 50mg of grades of hypromellose are available which differ in ranitidine every hours.

The first two numbers represent the amount of ranitidine. Rashes are powder or granules, practically odorless, hygroscopic. Hepatic injury, CNS effects and Solubility : haematological changes are rare, mostly seen in the It is practically insoluble in hot water, in elderly and seriously ill patients.

It Polymer : dissolves in cold water forming a colloidal solution. Method of tablet formulation: All the ingradient in respective formulae were passed through sieve no.

Then they were thoroughly triturated in a mortar and pestle to get a homogeneous mixture. The tablets were prepared by direct compression method.

Different viscosity grades of HPMC ionic,hydrophilic polymer. It is prepared from purified were used as sustained release polymer. Sodium cellulose,which is obtained from cotton linters or wood bicarbonate was selected as gas generating agent. The cellulose is then treated with an alkali like Microcrystaline cellulose MCC and lactose were used sodium hydroxide to produce swollen alkali cellulose.

Apart from these magnesium state was used as The alkali cellulose is then treated with chloro methane lubricant. Department of Botany, D. Background: Cardiometabolic syndromes are the co-occurrence of metabolic abnormalities such as obesity, insulin resistance, atherogenic dyslipidemia, and hypertension. Cardiometabolic disorders includes type2 diabetes mellitus, metabolic syndrome, and cardiovascular diseases.

The prevalence of cardiometabolic disorders are growing in epidemic proportions all over the world; hence cardiometabolic d In organic chemistry, the largest families of organic compounds belong in the heterocyclic compounds. In our daily life, the importance of heterocyclic compounds is very essential. It has a broad range of applications in medicinal chemistry. Benzotriazole is a bicyclic heterocyclic system consisting of three nitrogen atoms and a fused benzene ring, shows wide range of biological and pharmacologica Micro sponges are patented polymeric drug delivery systems consisting of porous microspheres.

The physical appearance of microsponges is tiny spherical sponge-like with the surface with large spores. Micro sponges are typically used and nowadays used as the oral dosage form. The inert and indestructible tiny spherical particles do not pass through the skin.

But, it collects in the tiny nooks and c Patients and Methods: We made this study on subjects men divided into four groups 30 healthy control The process by which the ranitidine hydrochloride is produced also needs to be one which is convenient to operate on a plant scale. In particular it is desirable that the hydrochloride should be prepared with concentrated hydrochloric acid and that the solvent for crystallisation should be readily recoverable.

In addition, the product should be in a form that is readily filtered off and easily dried. It is also desirable that, if required, the product can be recrystallised from the same solvent system. Ranitidine hydrochloride has been obtained in a crystalline form, designated Form 1, by dissolving ranitidine in industrial methylated spirit containing hydrogen chloride and adding ethyl acetate to the solution, as described in the above mentioned British Patent Specification.

This procedure, however, does not have the desirable features of a manufacturing process described above and Form 1 of the hydrochloride salt has unsuitable filtration and drying characteristics.

It has now been discovered that ranitidine hydrochloride can be prepared in a new crystalline form having more advantageous properties and the manufacturing process for the said new crystalline form fulfills the desirable features described above.

The present invention thus provides ranitidine hydrochloride in a new crystalline form designated Form 2. Form 2 has been found generally to have larger crystals than the hitherto known Form 1 and exhibits more favourable filtration and drying characteristics.

Furthermore, Form 2 is less hygroscopic than Form 1, which is an additional advantage in view of the sensitivity of ranitidine hydrochloride to moisture. These will now be discussed in more detail. The infra-red spectrum of Form 2 ranitidine hydrochloride as a mull in mineral oil shows the following main peaks:.

The X-ray diffraction pattern of Form 2 ranitidine hydrochloride may be obtained by loading the material into a 0. The weighted mean values of X-ray wavelengths used for the calculations were CuK a 1. Form 2 ranitidine hydrochloride may be formulated for administration in any convenient way and the invention includes within its scope pharmaceutical compositions comprising Form 2 ranitidine hydrochloride adapted for use in human or veterinary medicine.

Such compositions may be presented for use in a conventional manner with the aid of a pharmaceutically acceptable carrier or excipient and may also contain if required other active ingredients, e.

H 1 -antagonists. Thus the hydrochloride salt according to the invention may be formulated for oral, buccal, topical, parenteral, or rectal administration. Oral administration is preferred, particularly in the form of tablets and capsules. For oral administration, the pharmaceutical composition may take the form of for example, tablets, capsules, powders, solutions, syrups or suspensions prepared by conventional means with acceptable excipients.

For buccal administration the compositions may take the form of tablets or lozenges formulated in conventional manner. Form 2 ranitidine hydrochloride may be formulated for parenteral administration by bolus injection of continuous infusion. Formulations for injection may be presented in unit dosage form in ampoules, or in multi-dose containers, with an added preservative.

Alternatively, the active ingredient may be in powder form for reconstitution with a suitable vehicle, e. Form 2 ranitidine hydrochloride may also be formulated in rectal compositions such as suppositories or retention enemas, e. For topical application, Form 2 ranitidine hydrochloride may be formulated as ointments, creams, gels, lotions, powders or sprays in a conventional manner. For internal administration a convenient daily dosage regime of Form 2 ranitidine hydrochloride is 1 to 4 doses to the total of some 40 mg to 1.

The present invention also provides a process for the preparation of Form 2 ranitidine hydrochoride which comprises crystallising ranitidine hydrochloride from a solution thereof in a solvent under conditions which yield Form 2 ranitidine hydrochloride.

The precise condition under which Form 2 ranitidine hydrochloride is formed may be empirically determined and it is only possible to give a number of methods which have been found to be suitable in practice. Thus, for example, Form 2 ranitidine hydrochloride may be prepared by crystallisation under controlled conditions. In particular, it can be prepared either from the corresponding free base by reaction with hydrochloric acid or by recrystallisation of previously isolated ranitidine hydrochloride.

In general the use of a hydroxylic solvent, e. In some cases it is necessary to add further organic solvent or a specific anti-solvent such as acetone in order to bring the Form 2 crystals out of solution. It is preferable to use concentrated hydrochloric acid e. Under these conditions, salt formation, as well as crystallisation, should preferably be carried out at an elevated temperature, for example within the above mentioned temperature ranges. It has been found that it may be advantageous to include in the starting solution, a small amount to water, additional to that in the hydrochloric acid e.

When the starting material is ranitidine hydrochloride e. Form 1 or Form 2, the desired Form 2 salt may be crystallised using similar conditions for crystallisation to those described above. Alternatively, the salt may be dissolved, e. In the case of some solvents, e. Form 2 ranitidine hydrochloride has proved to be readily isolable and can be filtered off from the crystallisation medium, if desired after cooling, and washed and dried.

If desired, the Form 2 ranitidine hydrochloride prepared as above may further be recrystallised using similar conditions for crystallisation to those described above.

In order that the invention may be more fully understood the following Examples are given by way of illustration only. One equivalent about 5. Concentrated hydrochloric acid 1. Further concentrated hydrochloric acid about 0.

Form 1 ranitidine hydrochloride 10 g was warmed in a mixture of methanol 15 ml and acetone 15 ml. One equivalent about 1. After 0. Celite 0.



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