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bodytemple75
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**This is all the info I could come up with making your own suppositories. May help, and does not seem difficult and time consuming.
It is a legit medical practice. It seems to have a good absorbtion rate, so if it does work better, worth a try.
Here is the the info on the procedure:-----(below article)----------
How to Make Medical Rectal Suppositories
(article from: 1998-2003 ContinuingEducation.com)
Preparation:
Mold Calibration (Preparation of Blanks) for Fusion or Cold Compression
1. Prepare the suppository molds and confirm that the cavities are clean and dry.
2. Obtain and melt sufficient suppository base to fill six to 12 molds.
3. Pour the molds, cool and trim.
4. Remove the suppositories and weigh.
5. Divide the total weight by the number of blank suppositories prepared to obtain the average weight of each suppository for this particular base.
6. Use this weight as the calibrated value for that specific mold using that specific lot of suppository base.
Five different steps involved in the preparation of suppositories include (1) mold preparation, (2) base preparation, (3) preparation of the active drug, (4) mixing and pouring, and (5) cooling and finishing.
1. Mold Preparation:
Molds should be clean and dry at the start. Good suppository bases, if prepared and heated properly and if the mold is clean and dry, should require no lubricants. However, if it is absolutely necessary to use a lubricant, the molds should be lubricated properly. If a water soluble base is used, light mineral oil is a good lubricant. If an oil soluble base is used, glycerin or propylene glycol is a good lubricant. It is critical to use only enough lubricant to provide a very thin layer on the walls of the mold. Excessive lubricant will pool at the tip of the mold and result in deformed suppositories. Inadequate lubricant will result in suppositories that are difficult to remove. The lubricant can be applied by spraying or by using a cloth to which the lubricant has been added and wiping the molds. Some pharmacists have reported satisfactorily using a commercial vegetable spray for mold lubrication. The mold should be equilibrated at room temperature for the pouring procedure.
2. Base Preparation
The preparation of the base will be determined by the type of base that will be used. Cocoa butter must be grated for hand molding and may be grated if desired for the fusion method for melting on a water bath. If fusion is used, caution must be observed to not exceed about 34-35°C to prevent the formation of an unstable polymorph of the cocoa butter base, which may result in formation of the alpha form resulting in a low melting point suppository that would melt at room temperature and may stick to the mold. Cocoa butter and fatty acid bases should be melted only to form a fluid, mixable, pourable liquid that is still creamy-hazy in appearance.
Polyethylene glycol bases can be melted using a water bath or the judicious use of direct heat to a temperature of approximately 55-60°C. PEG bases are very heat stable, but should not be heated excessively. They should be gently heated to just a few degrees above their melting range.
3. Preparation of the Active Drug
The drug should be comminuted to a uniform, small particle size to ensure even distribution of the drug throughout the base and to minimize settling in the melt. The best source of ingredients for the extemporaneous compounding of suppositories is the pure drug powder. If pure powder is unavailable, commercial dosage forms such as injections, tablets, capsules, etc. can be used. If these dosage forms are used, the presence of any excipients must be considered as to the influence they might have on the physicochemical properties and stability of the finished product, since it is rarely feasible to extract the active drug from the dosage forms.
In general, a maximum quantity of excipient to be incorporated is about 30% of the blank weight of the suppository. For example, for a 2 mL disposable mold, the maximum excipient would be about 600 mg.
Liquids may occupy too much volume to be easily incorporated and the vehicles may not be compatible with selected suppository bases. Tablets and capsules may contain excessive powder that may result in suppositories that are too brittle. If a large quantity of liquid is to be incorporated into an oily suppository base, it may be necessary to prepare a water-in-oil emulsion. For PEG bases, a higher percent of the higher molecular weight PEGs can be used to accommodate the liquid.
4. Mixing and Pouring
The drug is either mixed directly into the base or is "wetted" prior to incorporation. Mixing can be done using a stirring rod or a magnetic stirring setup. Sufficient time is utilized for the mixing process to obtain a uniform distribution of the drug but not too long to result in either drug or base deterioration. When the melt is ready, it may be poured into the mold, which has been brought to room temperature. A cold or frozen mold should not be used as fractures and fissures may occur throughout the suppository. Starting at one end of the mold, each cavity is slowly filled, being careful not to incorporate air bubbles into the suppository, and a small excess of material allowed to "build up" on the top of the mold and the next cavity is filled, etc. Once pouring is initiated, do not stop the pouring process until all the molds have been filled; this will prevent layering in the suppositories. A 10 mL syringe, or other suitable size, can be filled with the melt and used to fill the molds if one is careful not to let the melt cool too rapidly. The mold should be at room temperature so the melt does not prematurely solidify as it is poured down the sides of the mold cavity. Premature solidification could result in unfilled mold tips and deformed suppositories. If disposable molds are used, PEG melts should be poured at a minimum temperature since some molds may collapse at about 70°C. If the melt is poured around 60°C, this should not occur. Other bases should be kept near their respective melting temperatures.
5. Cooling and Finishing
The molds can be allowed to set for 15-30 minutes at room temperature followed by refrigeration for an additional 30 minutes, if necessary. Excess material is removed from the top of the mold (the back of the suppository). This can be easily accomplished by dipping the blade of a stainless steel spatula in a beaker of warm water and using it to cut off the excess material. This will also serve to place a nice smooth surface on the backside of the suppository. Suppositories can be removed carefully from the molds, packaged and labeled. If the suppository mold is still cool, the suppositories should be slightly contracted which will effect easier removal from the mold. Individual suppositories can be wrapped using foil wrappers, if desired. Wrapping, though not necessary, does present an elegant product to the patient.
Packaging
Suppositories are best individually wrapped or dispensed in the disposable molds in which they are prepared. If suppositories are not packaged properly, they may become deformed, stained, broken or chipped. Foil suppository wrappers are available in various colors for the compounding pharmacist. Wrapped suppositories are usually placed in wide-mouth containers or in slide, folding or partitioned boxes for dispensing to the patient. Suppositories that are dispensed in disposable molds are often placed in cardboard sleeves or plastic bags, labeled and dispensed.
Storage / Labeling
Suppositories must be protected from heat and may be stored in a refrigerator. They should not be frozen. Glycerin and polyethylene glycol-based suppositories should be protected from moisture, as they tend to be hygroscopic.
It is usually a good idea, if the suppositories are wrapped, to add to the label, "Unwrap, moisten and insert.." or "Unwrap and insert..".
It is a legit medical practice. It seems to have a good absorbtion rate, so if it does work better, worth a try.
Here is the the info on the procedure:-----(below article)----------
How to Make Medical Rectal Suppositories
(article from: 1998-2003 ContinuingEducation.com)
Preparation:
Mold Calibration (Preparation of Blanks) for Fusion or Cold Compression
1. Prepare the suppository molds and confirm that the cavities are clean and dry.
2. Obtain and melt sufficient suppository base to fill six to 12 molds.
3. Pour the molds, cool and trim.
4. Remove the suppositories and weigh.
5. Divide the total weight by the number of blank suppositories prepared to obtain the average weight of each suppository for this particular base.
6. Use this weight as the calibrated value for that specific mold using that specific lot of suppository base.
Five different steps involved in the preparation of suppositories include (1) mold preparation, (2) base preparation, (3) preparation of the active drug, (4) mixing and pouring, and (5) cooling and finishing.
1. Mold Preparation:
Molds should be clean and dry at the start. Good suppository bases, if prepared and heated properly and if the mold is clean and dry, should require no lubricants. However, if it is absolutely necessary to use a lubricant, the molds should be lubricated properly. If a water soluble base is used, light mineral oil is a good lubricant. If an oil soluble base is used, glycerin or propylene glycol is a good lubricant. It is critical to use only enough lubricant to provide a very thin layer on the walls of the mold. Excessive lubricant will pool at the tip of the mold and result in deformed suppositories. Inadequate lubricant will result in suppositories that are difficult to remove. The lubricant can be applied by spraying or by using a cloth to which the lubricant has been added and wiping the molds. Some pharmacists have reported satisfactorily using a commercial vegetable spray for mold lubrication. The mold should be equilibrated at room temperature for the pouring procedure.
2. Base Preparation
The preparation of the base will be determined by the type of base that will be used. Cocoa butter must be grated for hand molding and may be grated if desired for the fusion method for melting on a water bath. If fusion is used, caution must be observed to not exceed about 34-35°C to prevent the formation of an unstable polymorph of the cocoa butter base, which may result in formation of the alpha form resulting in a low melting point suppository that would melt at room temperature and may stick to the mold. Cocoa butter and fatty acid bases should be melted only to form a fluid, mixable, pourable liquid that is still creamy-hazy in appearance.
Polyethylene glycol bases can be melted using a water bath or the judicious use of direct heat to a temperature of approximately 55-60°C. PEG bases are very heat stable, but should not be heated excessively. They should be gently heated to just a few degrees above their melting range.
3. Preparation of the Active Drug
The drug should be comminuted to a uniform, small particle size to ensure even distribution of the drug throughout the base and to minimize settling in the melt. The best source of ingredients for the extemporaneous compounding of suppositories is the pure drug powder. If pure powder is unavailable, commercial dosage forms such as injections, tablets, capsules, etc. can be used. If these dosage forms are used, the presence of any excipients must be considered as to the influence they might have on the physicochemical properties and stability of the finished product, since it is rarely feasible to extract the active drug from the dosage forms.
In general, a maximum quantity of excipient to be incorporated is about 30% of the blank weight of the suppository. For example, for a 2 mL disposable mold, the maximum excipient would be about 600 mg.
Liquids may occupy too much volume to be easily incorporated and the vehicles may not be compatible with selected suppository bases. Tablets and capsules may contain excessive powder that may result in suppositories that are too brittle. If a large quantity of liquid is to be incorporated into an oily suppository base, it may be necessary to prepare a water-in-oil emulsion. For PEG bases, a higher percent of the higher molecular weight PEGs can be used to accommodate the liquid.
4. Mixing and Pouring
The drug is either mixed directly into the base or is "wetted" prior to incorporation. Mixing can be done using a stirring rod or a magnetic stirring setup. Sufficient time is utilized for the mixing process to obtain a uniform distribution of the drug but not too long to result in either drug or base deterioration. When the melt is ready, it may be poured into the mold, which has been brought to room temperature. A cold or frozen mold should not be used as fractures and fissures may occur throughout the suppository. Starting at one end of the mold, each cavity is slowly filled, being careful not to incorporate air bubbles into the suppository, and a small excess of material allowed to "build up" on the top of the mold and the next cavity is filled, etc. Once pouring is initiated, do not stop the pouring process until all the molds have been filled; this will prevent layering in the suppositories. A 10 mL syringe, or other suitable size, can be filled with the melt and used to fill the molds if one is careful not to let the melt cool too rapidly. The mold should be at room temperature so the melt does not prematurely solidify as it is poured down the sides of the mold cavity. Premature solidification could result in unfilled mold tips and deformed suppositories. If disposable molds are used, PEG melts should be poured at a minimum temperature since some molds may collapse at about 70°C. If the melt is poured around 60°C, this should not occur. Other bases should be kept near their respective melting temperatures.
5. Cooling and Finishing
The molds can be allowed to set for 15-30 minutes at room temperature followed by refrigeration for an additional 30 minutes, if necessary. Excess material is removed from the top of the mold (the back of the suppository). This can be easily accomplished by dipping the blade of a stainless steel spatula in a beaker of warm water and using it to cut off the excess material. This will also serve to place a nice smooth surface on the backside of the suppository. Suppositories can be removed carefully from the molds, packaged and labeled. If the suppository mold is still cool, the suppositories should be slightly contracted which will effect easier removal from the mold. Individual suppositories can be wrapped using foil wrappers, if desired. Wrapping, though not necessary, does present an elegant product to the patient.
Packaging
Suppositories are best individually wrapped or dispensed in the disposable molds in which they are prepared. If suppositories are not packaged properly, they may become deformed, stained, broken or chipped. Foil suppository wrappers are available in various colors for the compounding pharmacist. Wrapped suppositories are usually placed in wide-mouth containers or in slide, folding or partitioned boxes for dispensing to the patient. Suppositories that are dispensed in disposable molds are often placed in cardboard sleeves or plastic bags, labeled and dispensed.
Storage / Labeling
Suppositories must be protected from heat and may be stored in a refrigerator. They should not be frozen. Glycerin and polyethylene glycol-based suppositories should be protected from moisture, as they tend to be hygroscopic.
It is usually a good idea, if the suppositories are wrapped, to add to the label, "Unwrap, moisten and insert.." or "Unwrap and insert..".
