Herbal Drug Delivery Systems PDF
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This document provides an outline for the manufacture and quality control of herbal drug delivery systems. It covers topics like medicinal plants, herbs, herbal materials, and herbal preparations. The document includes information on collection, processing, formulation, and quality control tests.
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PHARM 131: LOREM IPSUM ANUFACTURE AND QUALITY M CONTROL OF HERBAL DRUG DELIVERY SYSTEMS Professor, RPh | Reviewed: Aug 11, 2024 | Last Edited: PROCESSING (continued) OUTLINE...
PHARM 131: LOREM IPSUM ANUFACTURE AND QUALITY M CONTROL OF HERBAL DRUG DELIVERY SYSTEMS Professor, RPh | Reviewed: Aug 11, 2024 | Last Edited: PROCESSING (continued) OUTLINE APPENDIX HERBAL MEDICINE MEDICINAL PLANTS HERBAL MEDICINE HERBS MEDICINAL PLANTS HERBAL MATERIALS ild or cultivated plants used for medicinal purposes W HERBAL PREPARATIONS ○ Hinapyawan ‘yung Sampung Halamang Gamot: FINISHED HERBAL PRODUCTS Akapulko(Senna alata) NIT PROCESSES IN THE PRODUCTION OF HERBAL U Ampalaya(Momordica charantia) MEDICINES Bawang(Allium sativum) COLLECTION AND PROCESSING OF PLANT Bayabas(Psidium guajava) MATERIALS Lagundi(Vitex negundo) COLLECTION Niyog-niyogan(Combretum indicum) PREFORMULATION STUDIES Sambong(Blumea balsamifera) PREFORMULATION STAGES Tsaang Gubat(Carmona retusa) FORMULATION DEVELOPMENT Pansit-Pansitan(Peperomia pellucida) STANDARDIZATION Yerba Buena(Clinopodium douglasii) FORMULATION BOTTLENECKS Herbal Medicines PHARMACOLOGICAL INVESTIGATION ○ Herbs ○ Herbal Materials MANUFACTURING ○ Herbal Preparations QUALITY CONTROL TESTS ○ Finished Herbal Products FORMULATION DEVELOPMENT INTRODUCTION HERBS IMPORTANCE OF FORMULATION Includecrude materialswhich could be derived from: FORMULATION ○ lichen WHY FORMULATE? ○ algae GOALS IN FORMULATION ○ fungi FACTORS TO CONSIDER IN FORMULATION ○ higher plants FORMULATION PROCESS leaves IDENTIFYING THE OPTIMUM STAGE flowers IDENTIFY THE METHOD OF MANUFACTURE fruit TRIAL FORMULATION fruiting bodies PHARMACEUTICAL EXCIPIENTS seeds SELECTION OF OPTIMUM FORMULA stems HERBAL DRUG FORMULATION wood TABLET HERBAL FORMULATION bark TABLET HERBAL FORMULATIONS roots LIQUID HERBAL FORMULATION rhizomes LIQUID HERBAL FORMULATIONS or other parts FLAVORS ○ may beentire,fragmented, orpowdered SELECTION GUIDE SEMI-SOLID HERBAL FORMULATIONS HERBAL MATERIALS SEMI-SOLID HERBAL FORMULATIONS Include in addition to herbs: CONCLUSION ○ fresh juices QUALITY ASSURANCE IN MEDICINAL PLANT RESEARCH ○ gums QUALITY ○ fixed oils PLANT ○ essential oils NATURE ○ resins MAN ○ dry powdersof herbs PROCESSING PACKAGING AND LABELING HERBAL PREPARATIONS Thebasis for finished herbal products RANS TEAM MEMBERS T 1 bit.ly/TransDatabase ○ May include comminuted or cut herbal materials, xtracts, tinctures, and fatty oils of herbal materials e PREFORMULATION STAGES ○ Producedbyextraction,fractionation,purification, e need to know the biomarker of the drugs W concentration, or other physical or biological ○ Ex. how will you trace lagundi in the body? processes, and also include preparations made by but the challenge is here, sometimes the steeping or heating herbal materials in alcoholic biomarker for this can be the same as others beverages/honey or other materials making it harder to identify who is causing the effect FINISHED HERBAL PRODUCTS ○ Herbal products are made of multiple constituents onsist of herbal preparations madefromoneormore C making it helpful to target as biomarkers herbs Stage 1: Physicochemical properties and analytical May contain excipientsin addition to the API testing for drugs (analytical profile) Stage 2: Data supporting the development of dosage UNIT PROCESSES IN THE PRODUCTION OF HERBAL forms MEDICINES ○ stability, incompatibility, and solid-state 1. Collection and processing of plant material characteristics; selection of appropriate methods for 2. pre-formulation studies dosage from eval 3. formulation development 4. pharmacological investigation Stage 3: support for quality controlandfinishedproduct manufacturing ○ revisedpharmaceuticaldata,specifications,analytical COLLECTION AND PROCESSING OF PLANT methods of the interim develeoped product, issues MATERIALS regarding difficulty of QC COLLECTION mahalaga raw ‘to kapag mag-thesis ka nito haha FORMULATION DEVELOPMENT hould follow guidance such as theWHOGuidelineon S agriculture and collection practices (GACP) for medicinal plants See FORMULATION DEVELOPMENT for the NOTE ○ You need to know which part to collect xtended lecture on formulation development. e Anongpartdawngampalayayung“anti-diabetic” = leaves FROM A PARTICULAR VARIETY Plant materialsMUSTbe: ○ collected fromonly one source ○ collected with thesame harvest season ○ presented forauthentication Philippine National Museum Bureau of Plant Industry Plant materials must be ○ washed to remove dirt ○ subjected togarblingtoremove other materials ○ milled to reduce particle size and sieved to ensure uniformity ○ properly stored until used in the formula and production STANDARDIZATION Handle materials so that it is not detrimental to the product Herbal material should not come into direct contactwith soil Not exposed directly to the sun (unless sun-drying is needed) Protected from rain and microbiological contamination PREFORMULATION STUDIES Investigatethephysicalandchemicalpropertiesofadrug substance alone and when combined with excipients Overall objective is to generate info useful to the formulator in developing stable and bioavailable dosage forms Ex. sambong - surveying different plants ○ they let the patient drink sambong but the patients complained about not being able to sleep coz they ORMULATION BOTTLENECKS F kept going to pee Use of multiple ingredients ○ researchingthispropertytheywereabletocheckthat Inconsistency of finished formulations sambong can remove kidney stones :0 Overlapping of chemical and chromatographic profiles Ex. Trial on COVID-19 Stability of formulations RANS TEAM MEMBERS T 2 bit.ly/TransDatabase Difficulty in developing standards ○ LDR; difference is quality T QC may not be properly done in supplements PHARMACOLOGICAL INVESTIGATION MANUFACTURING Harvesting Weighing and assigning a batch number Washing Garbling Drying ○ NMT 6% moisture ○ Oven drying (< 60ºC) Some constituents might evaporate at higher temp. and we don’t want that. Milling and sieving Storage rug Formulation D Manufacturing ○ Target identification to regulatory approval -> 20+ years QUALITY CONTROL TESTS IMPORTANCE OF FORMULATION FORMULATION ee QUALITY ASSURANCE IN MEDICINAL S Processesundertakentoprovideasuitabledrugdelivery NOTE PLANT RESEARCH for the extendedlectureon system for a specific drug product quality control. Requires consideration of the physical chemical and biological properties of all theactiveandpharmaceutical ingredients to be used hysical P ○ really know who is the intended patient group ○ Appearance ○ Ex. Pedia - what is the usual dosage form for them? ○ Color API is soluble - syrup ○ Odor API is insoluble = suspension ○ Macroscopic These can be given except tablets ○ Microscopic ○ Ex. Diabetic - what dosage form is applicable? ○ Particle size can’t really use syrups coz it is 85% sucrose ○ Moisture content The active ingredient and excipients added must be Chemical compatible with one another to produce a stable, ○ Ash Content efficacious,attractive,easytoadministerandsafedosage ○ Extractives product ○ Heavy Metals Must be manufactured with appropriate measures of Microbiological quality control and packaged for stability ○ Standard plate count S. aureus WHY FORMULATE? Salmonella spp. o provide safe and convenient delivery of accurate T E. Coli dosage of drugs Molds and yeasts To protect drug substance from degradation Pharmacological/Toxicological ○ i.e: humidity and atmospheric oxygen ○ Bioassay To protect from gastric acid after oral administration ○ LD50 determination ○ i.e: enteric coated ○ Mutagenicity, clastogenicity, and antimutagenicity To conceal the taste or odor of the drug substance testing To provide liquid preparations for substances that are either insoluble or unstable in the desired vehicle FORMULATION DEVELOPMENT ○ i.e: suspensions INTRODUCTION To provide clear liquid preparations for convenient rug substances (API) are rarely administered alone D administration Herbal drug formulation is similar to synthetic drug ○ i.e:syrup and solutions formulation To provide rate-controlled release drug action Druggivenasapartofformulationcombinedwithoneor To provide optimal drug action for topicallyadministered more API or excipients to produce a suitable dosage form drug substances ○ Herbal Drug vs Herbal Supplement: To provide insertion of a drug into one of the body’s Supplements - no clinical trials = no dosing; orifices kayasinasabinila‘takekalangngtake’,butcan ○ i.e:suppositories lead to liver failure To provide replacement of the drug directly into the Drug - ranthroughclinicaltrials=safersince bloodstream or body tissues there are dosing studies, etc. ○ i.e:injections RANS TEAM MEMBERS T 3 bit.ly/TransDatabase PHARMACEUTICAL EXCIPIENTS OALS IN FORMULATION G sed to solubilize, suspend, thicken, dilute, emulsify, U Physically and chemically stable stabilize,preserve,color,flavorandturnmedicinalagents Technologically feasible into efficacious and appealing dosage forms ○ Kayang i-adapt ng industry = kaya i-manufacture Must be pharmaceutically inert and does not affect the Biologically Available active ingredient (compatibility studies) ○ Related sa bioavailability ○ Additional action is allowed so as to increase the effect of the active ingredient FACTORS TO CONSIDER IN FORMULATION Do not interfere with the quality control of the active hysical and chemical properties of the Active P ingredient Pharmaceutical Ingredient (API) ○ TLC of herbal plant material ○ Organoleptic property of the powdered drug Harmless in amounts used to exert their effect ○ Solubility (if extract) ○ Stabilityprofile SELECTION OF OPTIMUM FORMULA Desired product type aster Formula M Therapeutic effect of the API ○ The formulation that best meets the goals of the formulation FORMULATION PROCESS ○ The formula to be used for scale-up production Tested for Large Scale Production ○ Determination of the reproducibility of the formulation ○ Recordingofchangesinthequalityoftheformulation pre/post scale up Final Testing ○ Sent for Bioassay Testing ○ Muta/Clastogenicity Testing ○ Toxicology Testing HERBAL DRUG FORMULATION IDENTIFYING THE OPTIMUM STAGE heretheherbalmedicinewillbebestabsorbed(topical W ba, oral, or the like) IDENTIFY THE METHOD OF MANUFACTURE hysical and chemical properties of the herbal drug P Availability of equipment Herbal plant materials consist of various chemical Technological feasibility c onstituents ○ must consider the whole chemistry of the plant IDENTIFY THE METHOD OF MANUFACTURE Herbal plant materials are prone to microbial reformulation Studies P contamination Compatibility Studies ○ stringent quality control tests on microbial content Use of every excipient to the whole formulation Prone to contamination ○ Separations of different plant materials when TRIAL FORMULATION processing aboratory scale L ○ Small batches - 100g TESTS FOR TABLET HERBAL FORMULATION To determine: ablet hardness T ○ Optimum method of manufacture Tablet weight ○ Approximation of the percentages of the excipients Tablet size ○ Initial stability of the Drug Dosage Form Disintegration/Dissolution ○ Reporting of the possible problem with the Friability formulation Thin-Layer Chromatography RANS TEAM MEMBERS T 4 bit.ly/TransDatabase TABLET HERBAL FORMULATIONS ust consider the therapeutic action of the plant M SEMI-SOLID HERBAL FORMULATIONS ○ Ampalaya tablets -the diluent to be used taining of the skin with the use of the formulation S Hindi sugar/sucrose Careful consideration of the ointment/cream base to be Must consider the physical appearance of the plant used material Possibility of separation of the extract from the base ○ Sambong tablets - being fibrous in nature (multiple ○ Odor millings) ○ Taste Must consider the moisture content of the powder pH Determination ○
