manufacturing process of Aspirin.pptx

Manufacturing of aspirin with respect to processes in industry

1. Pharmaceutical industry: Aspirin 1

2. Introduction : Pharmaceutical industry produces a wide range of medications, drugs, and pharmaceutical products for treating medical conditions and improving human health. We will solely be discussing the manufacturing of acetylsalicylic acid otherwise known as Aspirin Aspirin is one of the safest and least expensive pain relievers on the marketplace. While other pain relievers were discovered and manufactured before aspirin, they only gained acceptance as over-the-counter drugs in Europe and the United States after aspirin's success at the turn of the twentieth century. 2

3. Historical background The compound from which the active ingredient in aspirin was first derived, salicylic acid, was found in the bark of a willow tree in 1763 by Reverend Edmund Stone of Chipping-Norton, England. Bayer marketed aspirin beginning in 1899 and dominated the production of pain relievers until after World War I. 3

4. Aspirin can be properad by reacting salicylic acid with an excess of acetic anhydride, using a strong acid catalyst. The reaction produces acetic acid (vinegar) as a side product. Aspirin exerts its painkilling effect by inhibiting production of molecules called prostaglandins. 4

5. Raw Materials: To produce hard aspirin tablets, corn starch and water are added to the active ingredient (acetylsalicylic acid) to serve as both a binding agent and filler, along with a lubricant. Binding agents assist in holding the tablets together; fillers (diluents) give the tablets increased bulk to produce tablets of adequate size. A portion of the lubricant is added during mixing and the rest is added after the tablets are compressed. Lubricant keeps the mixture from sticking to the machinery. Possible lubricants include: hydrogenated vegetable oil, stearic acid, talc, or aluminum stearate. Scientists have performed considerable investigation and research to isolate the most effective lubricant for hard aspirin tablets. 5

6. Manufacturing: The procedure for manufacturing hard aspirin tablets, known as  dry-granulation  or  slugging,  is as follows: 1. Chemical Synthesis: The primary step in aspirin tablet synthesis is the chemical reaction that converts salicylic acid (the starting material) into acetylsalicylic acid (aspirin). This reaction typically involves acetylation, where acetic anhydride or acetyl chloride is used as the acetylating agent. Reactors are used to facilitate this reaction. The reaction is usually carried out under controlled conditions of temperature and pressure.   2. Filtration and Purification: After the chemical reaction, the mixture may contain impurities, unreacted starting materials, and by-products. Filtration units, such as filter presses or vacuum filters, are used to separate the solid aspirin product from the reaction mixture. This step helps remove unwanted substances and purify the aspirin.   6

7. 3. Drying The purified solid product obtained from the filtration step may still contain residual moisture. Drying equipment, such as rotary dryers or fluidized bed dryers, is used to remove moisture and ensure the aspirin is in a dry, stable form suitable for further processing. 4. Mixing and Blending: Once dried, the aspirin is mixed with other excipients and additives to create the final tablet formulation. This step involves blending the aspirin powder with ingredients like binders, disintegrants, lubricants, and fillers. Mixing and blending equipment, such as ribbon blenders or cone blenders, ensure uniform distribution of these components. 5. Tablet Compression: The blended mixture is then compressed into tablet form using tablet compression machines. These machines use punches and dies to compress the powdered mixture into tablets of consistent size, shape, and weight. The tablets may have a specific design, such as bevelled edges or scoring lines, for easier handling and ingestion. 7

8. The first three steps in aspirin manufacture: weighing, mixing, and dry screening. Mixing can be done in a Glen Mixer, which both blends the ingredients and expels the air from them. In dry screening, small batches are forced through a wire mesh screen by hand, while larger batches can be screened in a Fitzpatrick mill. 8

9. 4. Mixing and Blending: Once dried, the aspirin is mixed with other excipients and additives to create the final tablet formulation. This step involves blending the aspirin powder with ingredients like binders, disintegrants, lubricants, and fillers. Mixing and blending equipment, such as ribbon blenders or cone blenders, ensure uniform distribution of these components. 5. Tablet Compression: The blended mixture is then compressed into tablet form using tablet compression machines. These machines use punches and dies to compress the powdered mixture into tablets of consistent size, shape, and weight. The tablets may have a specific design, such as bevelled edges or scoring lines, for easier handling and ingestion. 6. Coating (Optional): In some cases, aspirin tablets may undergo a coating process to improve their appearance, taste, stability, or to control drug release. Coating can be achieved using coating pans or fluid bed coaters. A coating solution containing polymers, pigments, and other additives is applied to the tablets and then dried. 9

10. This drawing illustrates the principle of compression in a single-punch machine. First, the aspirin mixture is fed into a dye cavity. Then, a steel punch descends into the cavity and compresses the mixture into a tablet. As the punch retracts, another punch below the cavity rises to eject the tablet. Finished aspirin tablets often have a line "scored" down the centre so that the tablet can be broken into two parts with ease. 10

11. 6. Coating (Optional): In some cases, aspirin tablets may undergo a coating process to improve their appearance, taste, stability, or to control drug release. Coating can be achieved using coating pans or fluid bed coaters. A coating solution containing polymers, pigments, and other additives is applied to the tablets and then dried. 7. Quality Control: Throughout the entire process, quality control measures are implemented to ensure that the aspirin tablets meet required standards for potency, uniformity, dissolution, and other critical parameters. Various analytical techniques, such as high-performance liquid chromatography (HPLC), are used to test the tablets at different stages of production. These industrial units and processes work in conjunction to produce aspirin tablets that are safe, effective, and consistent in quality. The pharmaceutical industry follows strict regulatory guidelines and good manufacturing practices (GMP) to ensure the quality and safety of the final product. 11

12. Thank you! 12