GALENICALS PPT....pptx

Galenicals notes 1st year notes

1. 9.GALENICALS PHARMACEUTICS TEAM LEADER:VIDHYA LEKSHMI K TEAM MEMBERS: RAAJKUMAR S RANJITH J

2. GALENICALS DEFINITION: Galenicals is a standard medicinal preparation (as an extract or tincture) containing usually one or more active constituents of a plant and made by a process that leaves the inert and other undesirable constituents of the plant undissolved. Medicines prepared according to the formulae of Galen. A medicinal preparation composed mainly of herbal or vegetable matter. It is prepared by extraction of crude vegetable drugs (active principles) with suitable solvents.

3. ABOUT GALEN: GALEN is a Greek anatomist whose theories formed the basis of European medicine until the renaissance . Claudius  Galen  was born in Pergamum (modern-day Turkey) of Greek parents. ... He compiled all significant Greek and Roman medical thought to date, and added his own discoveries and theories. His influence reigned supreme over medicine for 15 centuries after his death. Pharmaceutical Preparations are divided into two types: 1.Galenical preparation 2.Non – G alenical preparation. NOMENCLATURE: Galenicals: Owing to galen who discovered it. Menstruum: Solvent used for extraction (ex. water, alcohol, ether). Marc: The inert fibrous and other insoluble materials remaining after extraction.

4. Extraction: Extraction is the method of removing active constituents from a solid or liquid (plant or animal tissues) using a liquid solvent. Extraction defined as the treatment of the plant or animal tissues with solvent ,whereby the medicinally active constituents or API are dissolved and most of the inert matter remain undissolved. Extracts: Extracts can be defined as preparation of crude drugs which contain all the constituents which are soluble in the solvent . Types of extracts: Dry extracts: E.g . Belladona extract Soft extract(Ointment ,suppository): E.g. glycerrhiza extract Liquid: As tincture.

5. Solvents used in Extraction: Following solvents are generally used for extraction Water and Alcohol Water: It is used as a solvent for proteins ,colouring matter, gums, glycosides, sugars, alkaloidal salts, enzymes, many organic acids and most of the organic salts. Waxes, fats, fixed oils and most alkaloids are insoluble in water. Disadvantages: Fermentation, decomposition of the preparation, chance to produce undesirable substances and interfere with clarity of the preparation. Use of preservatives. Water causes hydrolysis of many substances. Larger amount of heat is required to prepare aqueous preparations. Alcohol: It is used as a solvent for alkaloids, alkaloidal salts, glycosides, volatile oils, and resins. It also dissolves many forms of colouring matter, tannins, many organic acids and salts. Gums, albuminous matter, waxes, fats, fixed oils and sugars those are not soluble in alcohol.

6. Advantages: Mould and bacterial cannot grow on more than 20%alcohol It is neutral and compatible with other products Non toxic Disadvantages: Costly Certain alcohols are used rarely. Factors affecting extraction process: Nature of drug Solvent Temperature pH Particle size

7. METHOD OF EXTRACTION: Expression Infusion Decoction Digestion Maceration Percolation Continuous hot percolation process\ Soxhlet extraction\ Soxhlation .

8. 1.EXPRESSION: Definition: It is a process of extraction of active constitution from the plant parts without using solvents (Menstruum) .It is done mechanically using special type of equipments . Eg . Extraction of different types of oils from plants seeds Groundnut seeds, castor seeds , mastured seeds, teel seeds etc. mainly applicable to seeds and fresh leaves. 2.INFUSION: It consists of pouring water over the drugs and then allowing it to keep in contact with water for the stated period , usually 15 minutes, with occasional stirring and finally filtering off the liquid. The marc is not pressed. The boiling water is commonly used as a solvent, since it has a greater solvent action than cold water.

9. Types of infusion: 1. Fresh infusion(Dilute infusion) 2. Concentrated infusion(Stock infusion) 1. Fresh (Dilute) infusion: The simplest of all the method of extraction A definite weight of the crude drug in a certain state of subdivision is prepared. The calculated amount of hot or boiling Menstruum (usually water) is added to the crude drug. Soak for a definite time During the period of infusion, the heat should be retained in the container and the content should be stirred Do not press or squeeze the marc otherwise colloidal cell content may be forced out giving a cloudy infusion. Such fresh infusion should be used within 12 hours. Eg . Fresh infusion of quassia

10. Dilute infusion of quassia: Rx. Concentrated infusion of quassia-125 ml Distilled water, cold Q.S to-1000 ml Preparation: Just mix Dose: 15 to 30 ml 2.Concentrated (stock) infusion: To avoid rapid decomposition to which the fresh (dilute) infusion are subjected. These preparations are not made by the concentration of the dilute infusion by evaporation , since thermal treatment will result in loss of the volatile principles. Concentrated infusions prepared with alcoholic Menstruum or contain alcohol as a preservative Concentrated infusion are not intended to be dispensed in the concentrated state, but upon use, are diluted with at least seven times their volume of water.

11. Eg.Concentrated infusion of quassia: Rx. Quassia, cut small-80gm Alcohol(90%)-250 ml Distilled water, cold to Q.S.-1000 ml. Infusion Apparatus: Consists of covered jar, made of earthenware, stainless steel, ceramic glass, porcelain) to which is fitted at certain height a perforated tray upon which the crude drug may be allowed to rest in water being poured over it. The plant may be enclosed loosely in a small muslin bag and suspended in the jar at a height where it will be just covered by the liquid.

12. 3.Decoction: Definition: Solution of the water soluble constituents of plant drugs prepared by boiling the drug with water. For extraction of drugs with water soluble and non-volatile constituents, and drugs of hard and woody nature. Should be freshly prepared. Preparation: Previously sliced drug barks or wood (5parts) is boiled with water (100 or 120 parts) in a vessel of enameled iron or earthenware for a definite length of time (15 min) counting from when the liquid starts to boil with occasional stirring. To obtain highly concentrated decoction , boiling is continued until the liquid reduced to a certain volume.

13. Allow to cool to about 40 degree C, press the marc and mix the resulting liquid to the decoction. At the end of decoction time, decoction is strained through the fine muslin or flannel according to the nature of marc. Then, the sufficient water is passed through the strainer to produce a definite volume. Eg Cinchona bark or wood(contain quinine) USES: Treatment of fever, malaria and as an appetite stimulant Also used in anemia, indigestion, gastrointestinal disorders, general fatigue.

14. Comparison between infusion and decoction: Item Infusion Decoction 1.Plant Soft structure (ex. Senna leaves) Hard woody structure(ex .Cinchona bark) 2.Menstruum Boiling or cold water Boiling water 3.Procedure Infusing the drug with cold or hot water Boiling the drug with water 4.Apparatus Infusion earthenware pot Any covered apparatus 5.Time Calculated as soon as water is added to drug Calculated as soon as the water begins to boil 6.Storage Used fresh within 12 hours Used fresh and when stored in refrigerator.

15. 4.Digestion: This process is a modified maceration in which extraction of drug is carried out at a higher temperature at which the active ingredients are not adversely affected. Use of higher temperature provides for enhanced solvent action of Menstruum. If the Menstruum is readily volatilized at the temperature employed, a reflux condensed , recovered and returned to the container. This process is applicable to thermostatic one. It is also known as accelerate maceration. Not applicable to volatile Menstruum Eg Gum, resins

16. 5.MACERATION: In this process solid ingredients are placed in a stoppered container with the whole of the solvent and allowed to stand for a period of at least 3 days (3-7 days) with frequent agitation , until soluble matter is dissolved. The mixture is then strained (through sieves\nets), the marc is pressed and the combined liquids clarified(cleaned by filtration) or by decantation, after standing. Types of Maceration: Simple Maceration: for organized and unorganized crude drug Eg : 1.Tincture of orange 2.Tincture of lemon Double Maceration: Concentration infusion of orange. Triple Maceration : The maceration process may be carried out with help of heat or stirring.

17. Simple Maceration: For organized drugs e.g. roots , stems, leaves etc Alcohol is used as a Menstruum. In this process, the drug is placed with the Menstruum in a closed vessel for seven days. At this period shaking is done occasionally. After seven days , the liquid is mixed with strained liquid Then expressed liquid is mixed with strained liquid Then again filter for obtaining the clear liquid. The final volume is not adjusted. Modified Maceration or Maceration with adjustment: For Unorganized drugs e.g Gum ,Resins Gum- Resins,Oleo gum-Resins In this process, the unorganized drug is placed with 4\5 th volume of Menstruum in a closed vessel for seven days.

18. At this period shaking is done occasionally After the stated period, the liquid is filtered and not necessary to press the marc After that ,the final volume is adjusted with the remaining quantity of 1\5 th volume of Menstruum through the filter. Double Maceration Process: It is carried out in the same way s simple maceration process, but Menstruum used is divided into two parts. In that process drug is macerated twice by using the Menstruum which is divided into two parts in such a manner that the same volume is used for each maceration. 1. Volume of Menstruum required for first maceration: -Vol. to be retained by the drug 2.Vol of Menstruum required for second maceration: Total vol. of Menstruum-Vol. of Menstruum used in first maceration  

19. In this process the whole drug is macerated for 48 hours with quantity of Menstruum for first maceration Strain the liquid and press the marc after 48hrs Then again macerated for 24 hours with remaining quantity of Menstruum for second maceration. Strain the liquid and press the marc after 24 hours Then mix the liquid obtained from the two maceration and allows it to stand for 14 days and then filter. Eg.Concentrated infusion of orange and concentrated compound infusion of chirata Triple Maceration Process: It is carried out in the same way as simple maceration process ,but Menstruum used is divided in to two parts. In that process drug is macerated thrice by using the Menstruum which is divided into three parts in a such manner that the same volume is used for each maceration.

20. Volume o f Menstruum required for first maceration: +Vol. to be retained by the drug b. Volume of Menstruum required for 2 nd and 3 rd maceration : In that the drug is macerated for one hour with a part of Menstruum required for first maceration and strained. Macerated again for one hour with a part of Menstruum for second maceration and strained Macerated again for one hour with a part of Menstruum for third maceration and strained After that marc is pressed lightly Then combine the liquids obtained from 2 nd and 3 rd maceration and evaporated it to a specific extent Then mix the liquids obtained from 1 st maceration and add alcohol 90%equal to 1\4 th of the volume of the finished product.  

21. Then adjust the volume with water. Allow this solution for 14 days and then filter E.g. Concentrated infusion of quassia, Liquid extract of senna Difference between maceration and infusion S\NO MACERATION INFUSION 1. Menstruum used is usually Cold or boiling water used as menstruum 2. Drug is made in contact with Menstruum for 2-7 days. Drug is made in contact with Menstruum for 15 mins 3. The process is conducted at room temperature. The process may or my not be conducted at room temperature. 4. Marc is pressed after maceration except in modified maceration Marc is not expressed 5. Volume is not made up in simple maceration but adjustment is made in modified maceration process Volume is not made in this process

22. Difference between organized and unorganized drug S\NO ORGANIZED DRUG UNORGANIZED DRUG 1. Drug along with the whole of the Menstruum is used in maceration process. Drug along with 4\5 th of the Menstruum is used in the maceration process 2. The period of maceration is 7 days The period of maceration is 2-7 days 3. Strain off the liquid and press the marc Decant the liquid marc is not pressed 4. Mix the pressed liquid with the macerate and clarify by filtration , filtrate not adjusted to volume. Filter the liquid and pass the remaining 1\5 th of the Menstruum through filter to make up the final volume. 5. Eg . Tincture of orange , tincture of lemon, tincture of capsicum Eg . Compound tincture of benzoin , tincture of tolu .

23. 6.PERCOLATION: It is continuous downward displacement of the solvent through the bed of crude drug material to get extract. Most frequently used to extract active ingredients in the preparation of tinctures and fluid extracts. It is the method of short successive maceration A percolator (a narrow, cone-shaped vessel open at bothends ) is generally used.

24. Steps in percolation : Size reduction : The drug to be extracted is subjected to suitable degree of size reduction, usually from coarse powder to fine powder. Imbibitionn : During imbibition the powdered drug is moistened with a suitable amount of menstruum and allowed to stand for four hours in a well closed container. Packing: After imbibition the moistened drug is evenly packed into the percolator. Maceration: After packing sufficient menstruum is added to saturate the material. The percolator is allowed to stand for 24 hours to macerate the drug. Percolation: The lower tap is opened and liquid collected therein is allowed to drip slowly at a controlled rate until 3/4 th volume of the finished product is obtained. Types of Percolation; 1.Simple Percolation 2. Modified Percolation 3. Reserved percolation

25. 1. SIMPLE PERCOLATION: Drugs 200gms Eg . i ) Tincture of Belladonna ii) Compound tincture of cardamom 2. MODIFIED PERCOLATION: Repeated maceration is more effective than simple. Multiple maceration – Solvent divided into equal multiple time considering the solvent retained by plant tissue. Used to prepare concentrated preparation. Imbibition For 4 hrs Maceration

For 24 hours Percolation and collect the percolate ie.3/4 th of the volume of finished preparation

26. 3 . RESERVED PERCOLATION : In this case the extraction is done through the general percolation procedure At the last, the evaporation is done under reduced pressure in equipment like a Climbing evaporator to the consistency of a soft extract (semi solid) such that all thewater is removed. This is then dissolved in the reserved portion which is strongly alcoholic and easily dissolves the evaporated portion with any risk of precipitation. ADVANTAGES: Requires less time than maceration.
Extraction of thermolabile constituents can be possible.

27. DISADVANTAGES Requires more time than soxhalation. More solvent is required. Skilled person is required. MACERATION PERCOLATION Time consuming and also extraction is not complete. Short time and more complete extraction Not required skilled operator Skilled operator is required For certain substances which are very less soluble in solvent and requires only prolonged contact with solvent. Special attention should be paid on particle size of material and throughout process. • Suitable method for less potent and cheap drugs Suitable method for potent and costly drugs MACERATION VS PERCOLATION

28. 7.SOXHALATION:

29. THE SOXHLET EXTRACTOR Continuous extraction of a component from a solid mixture. Boiling solvent vapors rise up through the larger side - arm. Condensed drops of solvent fall into the porous cup, dissolving out the desired component from a solid mixture.
When the smaller side-arm filled to overflowing, it initiates a siphoning action.
The solvent, containing the dissolved component, is siphoned into the boiler below residual solvent then drains out of the porous cup, as fresh solvent drops continue to fall into the porous cup.

30. ADVANTAGE: > Large amount of drug can be extracted with much smaller quantity of solvent. > Tremendous economy in terms of time, energy & ultimately financial inputs. > Small scale & used a batch-process.

> Becomes more economical when converted into continuous extraction. DISADVANTAGES: >Physical nature of drug.
>Solvent.
>Chemical constituent of drug.

31. SPIRITS: Spirits consists of alcoholic or hydro alcoholic solutions of volatile substances. Spirits are used internally for their medicinal value and as flavoring agents , and also applied externally or used by inhalation. For oral use, spirits are generally diluted with a portion of water to reduce the pungency of the spirit. Spirits should be stored in tight, light resistant containers and in a cool place.

32. Method of preparation of spirits: Simple Dissolution: Majority of the spirits are prepared by this method, which involves dissolving the solute in alcohol by agitation. Ex. Chloroform spirit, spirit of ether Solution with maceration: Macerating the leaves of the crude drug in a suitable solvent to extract the desired constituents. Purified water is added to extract the soluble matter. After expression the macerated leaves are added to prescribed quantity of alcohol, filtered and added to the final liquid. Ex . Peppermint spirit

33. Chemical reaction: Spirits are prepared by the chemical reaction between the ingredients. Ex. Aromatic ammonia spirit USP, Ethyl nitrite spirit Distillation: Spirits are prepared by using distillation process. Ex. Aromatic spirit of ammonia, Brandy, Whiskey Preparation of Chloroform Spirit: 1. Chloroform 2. Alcohol(90%) Chloroform spirit consists of a 5% v\v solution of chloroform in alcohol 90% It contains 83 to 87 % of alcohol. Dose: 0.3 to 1 ml Storage: Well closed container, in a cool place .

34. Tinctures: According to IP, Tinctures can be defined as alcoholic or hydro alcoholic solutions usually containing active principles of vegetables or animal origin. Methods of preparation. 1.Maceration process (Process M) 2.Maceration process(Process P) 1.Maceration(Process M): This method is suitable for drugs which contain large portion of soluble constituents and which can not be packed uniformly in percolator. Place the solid material with the whole of the Menstruum in a closed vessel and allow to stand for 7 days, shaking occasionally. Strain, press the marc and mix the liquids obtained and clarify by filtration. Ex. Capsicum tincture, Compound cinchona tincture.

35. 2.Percolation process (Process P): Most commonly employed in the preparation of official tinctures. Moisten the solid materials with a sufficient quantity of the Menstruum allow to stand for 4 hrs in a closed vessel, pack in a percolator and add sufficient of the Menstruum to saturate the materials. When the liquid commences to drip from the percolator ,close the outlet, add Menstruum and allow to stand for 24 hrs. Allow percolate to proceed slowly until the percolate measures about three quarters of the volume with Menstruum Press the marc , make up the volume with Menstruum. Ex. Aconite tincture, Belladona tincture, Compound cardamom tincture. Preparation of compound cardamom tincture: Cardamom seeds, Caraway, Cinnamon, Amaranth, Glycerin, Alcohol(45%).

36. Preparation: Cardamom seeds, caraway, cinnamon are powdered and mixed. Mixed powders are moistened with alcohol and percolated to about 9\10 th of the final product. Glycerin and amaranth are added and the final volume is made up with alcohol. Dose: 2-4 ml Use: Carminative Extracts : Extracts are the isolated soluble material from an insoluble residue, which may be liquid or solid, prepared by treating with a solvent. Types of Extracts: 1.Aqueous extracts: Prepared using water which are medicinal preparations intended to be used immediately after preparation. 2.Liquid extracts: Termed as fluid extracts, is a liquid preparation of crude drugs which contain ethyl alcohol as a solvent and also can act as preservative.

37. Soft extracts: Which are produced as semisolids or liquids of syrupy consistency(Glycerrhiza extract). Dry extracts: Dry extracts also known as powdered extracts or dry powders(Belladonna extract). FRUIT EXTRACTS FLAVOR EXTRACTS

38. REFERENCES: PHARMACEUTICS BOOK –R.M.MEHTA https:// www.slideshare.net/HarisKhan29/galenicals-galanical-preperations https:// www.slideshare.net/ravikumarpatil26/extraction-84783459 http://www.authorstream.com/Presentation/giri567-1757703-galenicals /