Pilot plant oral liquids.pptx

Pilot plant oral liquids
M.Pharm semester 1

1. Prepared by: Mr. Ashish R. Chaudhari Asst. Professor M.Pharm PILOT PLANT SCALE-UP FOR LIQUID ORALS

2. DEFINITIONS INTRODUCTION OBJECTIVES LIQUID DOSAGE FORM STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUIDS GENERAL CONSIDERATIONS PILOT PLANT SCALE UP FOR SUSPENSION PILOT PLANT SCALE UP FOR EMULSION REFERENCES CONTENTS

3. DEFINITIONS Plant :- It is a place where the 3 M’s that are Man, Material and Money are brought together for the manufacturing of products. Pilot Plant :- It is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of liable practical procedure of manufacturing. Scale-up :- The art for designing of prototype using the data obtained from the pilot plant model.

4. OBJECTIVES To avoid the scale up problems To identify the crucial features of the process Guideline for production and process control Evaluation and validation for process and equipment To provide master manufacturing formula with instructions for manufacturing procedure Update the processing equipment Evaluation of time and cost factors

5. Liquid Dosage Form Liquid dosage forms is a pharmaceutical product, involving a mixture of active drug components and non- drug component (excipients) in the form in which it is marketed for use. Liquid state form are meant for internal, parental or external use. They are available in monophasic and biphasic forms. Monophasic liquid dosage forms are true or colloidal solution. Water is mainly used as a solvent for majority of monophasic liquid dosage forms. The liquids which consist of two phases are known as biphasic liquids.

6. STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUIDS

7. 1- Reporting Responsibilities The goal of pilot plant scale is to facilitate the transfer of a product from the laboratory to production. The formulations continue to provide support to the production even after the transition in to production has been completed. There must be good relation between pilot plant and other departments. 2- Personnel Requirement •Have good theoretic knowledge of pharmaceutics. •Practical experience in liquid orals manufacturing industry. Chemical, physical, biochemical and medical properties of drugs. •Have the knowledge of computer and electronics. GENERAL CONSIDERATIONS

8. 3. Space Requirements:- Administration and information processing Physical testing area Standard equipment floor space Storage area

9. 4- Review of Formula A thorough review of each and every steps of formulation is important. The purpose of each ingredient and its contribution to the final product should be studied. In any modification in formula. it should be done as soon as possible in phase 3 trials. To allow time to generate meaning long term stability in a support of a proposed new drug application 5- Raw Materials One responsibility of pilot plant is the approval and validation of the active ingredient and excipient raw materials used in the pharmaceutical products. The quality of the active ingredients needs to be verified. Solvents Preservatives Antioxidants Solubilizers Organoleptic Agents

10. 6- Relevant Processing Equipments Almost all formulation development work is carried out on small relatively simple laboratory equipments The equipments that is most economic, the simplest, the most efficient should be selected Liquid pharmaceuticals processing tanks kettles, pipes, mills, filter housing and so for are most frequently fabricated from stainless steel Ease of cleaning should be considered if multiple products are to be manufactured in the same equipment.

11. Stages Of Operation A Tank selection B. Mixing C. Filtration and clarification D. Transfer and filling

12. 7- Process Evaluation Items that should be examined include the following-Mixing speed Mixing time Rate of addition of solvents, solution of drugs, slurries etc Heating and cooling rates Filter size Filling 8-GMP Considerations Equipment qualification Process validation Regular process review and revalidation Relevant written SOP Adequate provision for training of personnel A well defined technology transfer system An orderly arrangement of equipments

13. 9- Assurance During the scale up new product the analytic test methods transferred to the quality department The quality assurance staff should review the process to make sure that the proper analysis instrumentation is available and that personnel are trained to perform tests

14. 4 6 SUSPENSIONS Suspensions require more attention during scale up than simple solutions because of additional processing needs. Equipments :- vibrating feed system and power for production scale. high shear mixing equipment Slurries facilitate rapid and complete hydration of suspending agent when added to large portion of the vehicle. Active ingredients must be uniformly dispersed throughout the batch. Mixing at too high speed can result in entrapment of air, which may affect physical or chemical stability of the product.

15. 4 7 VACUUM UNIT VERSATOR Filteration – remove unwanted particles. Screens of 150 mesh, having 100 microns are used. Active ingredients – particle size 10 – 25 microns. Transfer and filling of finished suspension should be carefully monitored. It should be constantly mixed during transfer to maintain uniform distribution of the active ingredients.

16. 4 8 EMULSIONS Manufacturing of liquid emulsion products entails specialized procedures as result scale up into production equipment involves extensive process development and validation. Equipments :- mixing equipment homogenizing equipment screens pumps filling equipment High shear mixers may lead to air entrapment, this problem can be avoid by carrying out operation under controlled vacuum.

17. REFERENCE The theory & practice of industrial pharmacy by Leon Lachman, Herbert A. Lieberman, Joseph L. Kenig , 3 rd edition, published by Varghese Publishing house.