Knowledge of Pharma

M/s (Name and address of the company) __________________________________ Name of the product __________________________________________________ (Trade name, if any) (MFR No.) __________________________________________________________ (Batch No.) ____________________________________ Capsule size __________ (Batch size.) ____________________________________ Colour _______________ Date of Expiry _______________________________________________________ Date of commencement ________________________________________________        Sr.No. Ingredients Standards Q/C Report No. Label Claim Quantity Required Quantity actually used Remarks 1 2 3 4 5 6 7 8 TOTAL Raw material initially weighed and measured by _____________________...

Globex Method: The lipophillic fill and the shell formulation are stored in separate containers, both kept warm. The fill and the shell material are pumped through a concentric double capillary, with fill in the inner one. The fill is pumped in pulses to give fill volumes between 20 to 600 mg. Here, the formation of capsule depends upon the interfacial tension between the fill and shell material. The shell material possesses a higher surface tension. In attempt to reduce the surface tension, the droplet is formed. As a result of this the seamless round soft capsules are formed. The end of the double capillary is immersed in a cooling bath containing a liquid usually liquid paraffin which is kept at about 4 ˚C  Advantages: Seamless capsules, which are tamper-evident. Free of contamination or air entrapment. Risk of leakage is minimal. Capacity: 10,000-40,000 capsules per hour. Rotary Die Process: At the same time when two fi...

GELATIN PROPERTIES ACID OSSEIN FISH BLOOM(G)0 180-210 160-210 VISCOSITY, 6.67%,600(MPA,S) 2.7-3.2 3.0-3.5 MOISTURE (%MAX) 13.0 13.0 ASH (%MAX) 1. 1.0 PH ,1% SOLUTION 5.0-6.0 5.0-6.0 ISO IONIC POINT,PH 6.0-8.0 7.0-9.4 PARTICLE SIZE % PASSING 4 US # 100 100 SO2 (PPM MAX) 60 60 H2O2 60 60 CLARITY (45% solution in 30% glycerol) Clear no precipitate MICROBIAL STANDARDS TOTAL COUNT 500 500 E.COLI IN 10 GM Absent Absent P. AERUGINOSA IN 10 GM Absent Absent GELATIN MASS PREPARATION:  Ø   The Shell of the Soft Gelatin Capsules comprises of pure Pharmaceutical...

COMPOSITION OF SOFT GELATIN CAPSULE SHELL 1)       GELATIN           2)       PLASTICIZER                  --GLYCERIN                                                    --SORBITOL 3) WATER 4) PRESERVATIVES           --METHYL PARABEN                                                 ...

One piece hermetically sealed soft gelatin shell containing a liquid, a suspension or semisolid. Advantages Ø   Products can be encapsulated in various shapes - various sizes - various colors. Ø   Products with thick slurry type paste Medicaments to light oils and powders (with inert media) can be encapsulated. Ø   Unit doses. Ø   Lower dose of active ingredients. Ø   High accuracy in fill weights. Ø   Fewer inactive ingredients. Ø   Improved stability. Longer shelf life. Ø   Improved bioavailability. Ø   One piece Capsule - tamper proof. Ø   One piece Capsule - no problem of microbial contamination, oxidation and evaporation.            Ease of administration - oral, rectal and vaginal. Disadvantage Ø   Highly sensitive to temperature and humidity. PLANT LAYOUT Generally SGC manufacturing premise has two floor building on first floor the preparati...

Raw Material Testing: GELATIN             BLOOM             VISCOSITY             MOISTURE             PH             ISO IONIC POINT,PH             PARTICLE SIZE             SO2 (PPM MAX)             H2O2             CLARITY             MICROBIAL STANDARDS Water Fill material – powder                       Sem...