Tablet is a major category of solid dosage forms which are widely used worldwide. Extensive information is required to prepare tablets with good

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1 TABLET PRODUCTİON

2 Tablet is a major category of solid dosage forms which are widely used worldwide. Extensive information is required to prepare tablets with good quality at high standards. Based on preformulation studies, the optimal dosage forms are generally decided. When given orally, the solid dosage form tablet undergoes in vitro disintegration and dissolution followed by absorption through the gastrointestinal tract (GI). The in vivo biodistribution of drug which enters the systemic circulation then occurrs.

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5 SELECTION OF PHARMACEUTICAL EXCIPIENTS A tablet contains active ingredients as well as other substances known as excipients, which have specific functions. A pharmaceutical excipient is defined as an inactive ingredient or any component other than the active ingredient added intentionally to the medicinal formulation or everything in the formulation except the active drug. Pharmaceutical excipients are also called additives, pharmaceutical ingredients, or inactive pharmaceutical ingredients.

6 There are many reasons for selecting and adding these pharmaceutical excipients in formulations. In the preparation of various dosage forms, it is essential to combine pharmaceutical excipients with model drugs as adjuvants to prepare the solid dosage forms, mainly tablets. The pharmaceutical excipients make the drug into the final dosage forms. Physicochemical properties such as solubility, stability, metabolism, and even bioavailability of drugs can be varied by the pharmaceutical excipients.

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8 Pharmaceutical excipients are regarded as key ingredients not only to decide optimal dosage forms but also to change the physicochemical and biological parameters of drugs. With an aid of pharmaceutical excipients, drug efficacy can be maintained. Changes of other types of dosage forms for different routes of administration are also achieved. The excipients can also function for the preparation of dosage formulation during the manufacturing processes.

9 However, utilization of these pharmaceutical excipients is limited by the regulatory guidelines to be satisfied in the dosage formulations. In general, the regulatory guidelines require the following conditions for the use of excipients in the dosage formulations: (a) no harmful or toxicological effect and listed GRAS (generally recognized as safe), (b) good stability with no drug excipient incompatibility and by any impurities in the excipients, (c) no interference in quality validation and analytical tests, (d) satisfaction of regulatory issues and guidelines in all countries where the product is to be marketed, (e) no instability with primary packing materials, (f) ease of accessibility, distribution, and economical cost, (g) satisfaction for environmental issues, (h) be physiologically inert, (i) be physically and chemically compatible with the active substance and the other excipients in the formulation, and (j) no unacceptable microbiological burden.

10 Pharmaceutical Excipients Used in Tablet Formulations

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35 The Classification of Tablet Manufacturing Methods granulation direct compression wet granulation: suitable for drugs that are stable to moisture and heat dry granulation: suitable for drugs that are sensitive to moisture and heat powder compression : suitable for drugs that are sensitive to moisture and heat, fill material possessing, good flowability and compressibility crystal compression:suitable for drugs with proper crystal form and good flowability

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58 Single Punch Machine (Tablets) Upper and Lower Collar Collar locker

59 Operation of eccentric tableting machine: ( a ) filling; ( b ) compression; ( c ) ejection; ( d ) pushing from die table.

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