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level: Level 2

Questions and Answers List

level questions: Level 2

QuestionAnswer
PREPARATION OF FILLED HARD GELATIN CAPSULES The general steps of preparation:1) developing and preparing the formulation and selecting the size of capsule. 2) filling the capsule shells. 3) capsule sealing (optional) 4) cleansing and polishing the filled capsules.
DEVELOPING THE FORMULATION AND SELECTION OF CAPSULE SIZE 1 GOAL: 2 How to get to the goal?1 a capsule with accurate dosage, good bioavailability, ease of filling and production, stability and elegance 2 pharmaceutical processing pharmaceutical excipient
1) uniform powder mix, uniform drug distribution 2) 50~1000 mm, suitable for a drug of low dose (10mg or greater) 3) 10~20 microns, suitable for Drugs of lower dose, small particles required1) blending 2) comminution/milling 3) micronization
1 to produce the proper capsule fill volume; to provide cohesion to the powders, 2 to assist the break-up and distribution of the capsule contents 3 to enhance the flow properties of the powder mix 4 to facilitate wetting of the dry powder1 diluent/filler (e.g. Lactose, microcrystalline cellulose and starch) 2 disintegrants/disintegration agents (e.g. pregelatinized starch, croscarmellose and sodium starch glycolate) 3 lubricant or glidant (e.g. fumed silicon dioxide, magnesium stearate, calcium stearate, stearic acid, or talc (0.25%-1%)) 4 wetting agents (e.g. surfactants, as sodium lauryl sulfate)
The form of filling material in capsules:1) powder or granulate 2) pellet mixture 3) paste or wetted mass: the mixture of liquid and an inert powder (for aq. Liq) 4) capsule and 5) tablet 6) liquids: fixed or volatile oils (locking or sealed gelatin capsules) 7) Eutectic mixtures:
1 Why are capsule and tablet are in form of filling material in capsules? 2 Why are eutectic mixtures are in form of filling material in capsules?1 *employed to separate chemically incompatible agents or to add premeasured (as tablets) amounts of potent drug substances 2 mixed with a diluent or absorbent to separate the interacting agents and to absorb any liquefied material *magnesium carbonate, kaolin, light magnesium oxide
Examples of Fill in hard gelatin capsules1 Powder or granulate 2 Pellet mixture 3 Paste 4 Capsule 5 Tablet
FILLING HARD CAPSULE SHELLS Methods1 The “punch” method 2 The pouring method 3 Hand-operated capsule filling machines 4 Machines for industrial use
1 suitable for filling a small number of capsules in the pharmacy1 The “punch” method
1 Punch Method Steps 2 Punch Method for Non potent drugs 3 Punch Method for Potent Drugs1 1) placing the powder on paper, glass/ porcelain plate 2) forming the powder mix into a cake 3) punching the empty capsule body into the powder cake 2 The first filled capsules should be weighed. The other capsules should be weighed periodically. 3 Each capsules should be weighed.
Hand filling capsules can done by what method?Punch Method
suitable for filling a small number of capsules in the pharmacy suitable for granular materialThe pouring method
The process of working: separating the caps from empty capsules → filling the bodies → scraping the excess powder → replacing the caps → sealing the capsules → cleaning the outside of the filled capsulesMachines for industrial use
1 CAPSULE SEALING Steps 2 Make the capsules tamper-evident1 1) heat welding 2) Thermally bonding at 40-45℃ with the help of a melting-point-lowering liquid wetting agent 3) extemporaneously, by lightly coating the inner surface of the cap with a warm gelatin solution 2 seal with a colored band of gelatin
CLEANING AND POLISHING CAPSULES 1 Small amount of powder may adhere to the outside of capsules after filling. True or False 2 On a small scale, clean with a __ 3 On a large scale, clean with a __1 True 2 clean gauze or cloth. 3 cleaning vacuum
are made of gelatin, glycerin (or a polyhydric alcohol such as sorbitol) and water. Used to hermetically seal and encapsulate liquids, suspensions, pasty materials, dry powders and even preformed granules, pellets, tablets. oblong, oval or round in shape. Preservatives Single colored / two tonedSOFT GELATIN CAPSULES
1 Soft Gelatin Capsules may have preservative to __ 2 Preservatives:1 retard microbial growth 2 methyl/ propyl paraben
1 The advantages of soft gelatin capsules1 1) pharmaceutically elegant 2) easily swallowed by the patient
SOFT GELATIN CAPSULES: COMPONENTS1) gelatin 2) glycerin or polyhydric alcohol 3) water/moisture 4) preservative and colorant 6) marking and opaquants 8) Flavors may be added and up to 5% sucrose may be included for its sweetness and to produce a chewable shell.
PREPARATION OF SOFT GELATIN CAPSULES1 The plate process 2 The rotary die process (Robert Scherer,1933) - more efficient and productive 3 The reciprocating die process
1 (using a set of molds) 2 more efficient and productive 3 is similar to the rotary process in that ribbons of gelatin are formed and used to encapsulate the fill, but it differs in the actual encapsulating process.1 The plate process 2 The rotary die process 3 The reciprocating die process
1 The plate process1) placing a warm sheet of gelatin on the bottom plate of the mold 2) pouring the liquid-containing medications 3) placing the second sheet of gelatin on top of medication 4) putting the top plate of the mold into place 5) pressing the mold to form, fill, and seal the capsules simultaneously 6) removing and washing the capsule Today, this equipment can no longer be purchased.
The rotary die process1) Liquid gelatin is formed into two ribbons 2) The two ribbons are brought together bet twin rotating dies 3) Metered fill material is injected between the ribbons 4) These pockets of fill-containing gelatin are sealed
The reciprocating die process1) A set of vertical dies continually open and close to form rows of pockets in the gelatin ribbons. 2) These pockets are filled with the medication and are sealed, shaped, and cut out of the film. 3) The capsules fall into refrigerated tanks which prevent the capsules from adhering to one another.