How long does it take for a suppository to work. What are the common side effects of rectal suppositories. How to properly use glycerin suppositories for constipation relief. When should you consult a doctor before using suppositories.

Understanding Glycerin Suppositories for Constipation Relief

Glycerin suppositories are a common over-the-counter treatment for occasional constipation in adults. These small, bullet-shaped medications are inserted rectally and work by drawing water into the intestines, typically producing a bowel movement within 15 to 60 minutes. As a hyperosmotic laxative, glycerin offers quick relief for those struggling with infrequent bowel movements.

Are glycerin suppositories suitable for everyone? While generally safe for most adults, it’s crucial to understand their proper use, potential side effects, and when to seek medical advice. This comprehensive guide will explore the ins and outs of adult rectal suppositories, helping you make informed decisions about your digestive health.

How Do Glycerin Suppositories Work?

Glycerin suppositories function through a simple yet effective mechanism:

• They draw water into the intestines
• This increased water content softens stool
• The softened stool becomes easier to pass
• The extra fluid also stimulates bowel contractions

This combined action usually results in a bowel movement within 15 to 60 minutes after insertion. However, individual responses may vary depending on factors such as diet, hydration, and overall digestive health.

Normal Bowel Movement Frequency

Understanding what’s considered “normal” can help you determine if you truly need a laxative:

• Adults: Once daily to 1-2 times weekly
• Preschool-aged children: Once daily to once every other day

Is constipation always a cause for concern? Not necessarily. Occasional irregularity is common and can often be addressed through lifestyle changes. However, persistent constipation or sudden changes in bowel habits should be discussed with a healthcare provider.

Proper Usage of Adult Rectal Suppositories

To ensure the safe and effective use of glycerin suppositories, follow these step-by-step instructions:

1. Wash your hands thoroughly before and after use
2. Remove the suppository from its foil wrapper
3. If desired, moisten the suppository with lukewarm water (avoid petroleum jelly or mineral oil)
4. Lie on your left side with your right knee slightly bent
5. Gently insert the suppository into the rectum, pointed end first
6. Remain in this position for 15-20 minutes if possible

Should you wait for the suppository to melt completely? No, the suppository doesn’t need to melt entirely to be effective. The body’s natural processes will absorb and utilize the medication.

Special Considerations for Children

When administering a suppository to a child:

• Have the child lie on their side
• Straighten the lower leg and bend the upper leg toward the stomach
• Insert the suppository gently, pointed end first
• Hold the buttocks together for a few seconds
• Encourage the child to remain lying down for 15-20 minutes if possible

Potential Side Effects and Precautions

While generally safe, glycerin suppositories can cause some side effects. Common issues include:

• Rectal irritation or burning
• Abdominal discomfort or cramps
• Small amounts of mucus in the stool

When should you be concerned about side effects? If these symptoms persist or worsen, it’s important to consult your doctor or pharmacist promptly. More serious side effects, though rare, can occur and require immediate medical attention.

Serious Side Effects to Watch For

Seek medical help immediately if you experience:

• Severe or persistent abdominal pain
• Bloody stools
• Rectal bleeding
• Symptoms of dehydration (unusual decreased urination, dry mouth, fast heartbeat, dizziness)
• Signs of a serious allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing)

Can glycerin suppositories cause dependence? Yes, if used too frequently, they may lead to loss of normal bowel function and an inability to have a bowel movement without the product. This condition, known as laxative dependence, underscores the importance of using suppositories only as directed.

Precautions and Medical Considerations

Before using glycerin suppositories, it’s crucial to consider your overall health and any pre-existing conditions. Inform your doctor or pharmacist if you:

• Are allergic to glycerin or any other ingredients in the product
• Have a history of rectal bleeding
• Have been diagnosed with intestinal blockage or other bowel problems
• Experience persistent stomach/abdominal symptoms like nausea, vomiting, or pain
• Have noticed a sudden change in bowel habits lasting more than 2 weeks

Why is it important to disclose your full medical history? This information helps healthcare providers assess whether glycerin suppositories are safe and appropriate for your specific situation. In some cases, alternative treatments may be recommended.

Natural Alternatives for Constipation Relief

While suppositories can provide quick relief, addressing the root causes of constipation often involves lifestyle changes. Consider these natural approaches:

• Increase fluid intake, especially water
• Consume more high-fiber foods (fruits, vegetables, whole grains)
• Engage in regular physical activity
• Establish a consistent bathroom routine
• Manage stress through relaxation techniques

Can dietary changes alone resolve chronic constipation? For many people, these lifestyle modifications can significantly improve bowel regularity. However, persistent issues may require additional medical intervention or investigation of underlying causes.

When to Seek Medical Advice

While occasional constipation is common, certain situations warrant professional medical attention. Consult your doctor if:

• You don’t have a bowel movement after using the suppository
• Constipation persists despite lifestyle changes and over-the-counter treatments
• You experience unexplained weight loss, fever, or abdominal pain
• There’s blood in your stool or rectal bleeding
• You have a family history of colon cancer or inflammatory bowel disease

Why is it crucial not to ignore persistent digestive issues? Chronic constipation can sometimes be a symptom of more serious underlying conditions. Early detection and treatment of these conditions can lead to better outcomes and prevent complications.

Diagnostic Procedures for Chronic Constipation

If your doctor suspects an underlying issue, they may recommend:

• Blood tests to check for hormonal imbalances or other abnormalities
• Imaging studies like X-rays or CT scans to examine the digestive tract
• Colonoscopy to inspect the colon for structural problems or growths
• Anorectal manometry to assess muscle function in the rectum and anus

Understanding Laxative Types and Their Uses

Glycerin suppositories are just one type of laxative available for constipation relief. Understanding the different categories can help you make informed decisions about your digestive health:

1. Bulk-forming laxatives: These work by absorbing water and swelling in the intestines, creating larger, softer stools.
2. Osmotic laxatives: Similar to glycerin, these draw water into the colon to soften stool and increase bowel movements.
3. Stimulant laxatives: These trigger contractions in the intestinal muscles to move stool along.
4. Stool softeners: As the name suggests, these products soften the stool to make passage easier.
5. Lubricant laxatives: These coat the stool and intestinal lining to facilitate easier passage.

How do you choose the right laxative for your needs? The best choice depends on factors like the severity of your constipation, your overall health, and any medications you’re taking. Consulting with a healthcare provider can help you determine the most appropriate option.

Combining Laxatives with Other Treatments

In some cases, a multi-faceted approach to constipation relief may be recommended:

• Combining different types of laxatives for enhanced effect
• Using probiotics to support gut health
• Incorporating fiber supplements into your diet
• Exploring physical therapy options like pelvic floor exercises

Is it safe to use multiple constipation treatments simultaneously? While combining treatments can be effective, it’s crucial to do so under medical supervision to avoid potential interactions or side effects.

Long-Term Management of Digestive Health

While glycerin suppositories and other laxatives can provide short-term relief, maintaining long-term digestive health requires a comprehensive approach:

• Develop a balanced, fiber-rich diet
• Stay adequately hydrated throughout the day
• Incorporate regular exercise into your routine
• Manage stress through techniques like meditation or yoga
• Address any underlying medical conditions that may contribute to constipation
• Consider keeping a food and symptom diary to identify potential triggers

Can lifestyle changes alone prevent the need for laxatives? For many individuals, consistent healthy habits can significantly reduce the frequency of constipation episodes. However, some people may still require occasional or regular use of laxatives due to medical conditions or medications.

The Role of Gut Microbiome in Digestive Health

Emerging research highlights the importance of a healthy gut microbiome in maintaining regular bowel function. Consider these strategies to support your gut bacteria:

• Consume a variety of prebiotic foods (e.g., garlic, onions, bananas)
• Include fermented foods in your diet (e.g., yogurt, kefir, sauerkraut)
• Limit processed foods and artificial sweeteners
• Consider probiotic supplements under medical guidance

How long does it take to see improvements in gut health through dietary changes? While some people may notice changes within a few days, it often takes several weeks to months of consistent habits to significantly alter the gut microbiome and improve digestive function.

Special Considerations for Different Age Groups

Constipation can affect individuals of all ages, but treatment approaches may vary based on life stage and overall health:

Children and Adolescents

Constipation in younger individuals often requires a gentler approach:

• Encourage regular toilet habits and proper positioning
• Ensure adequate fluid intake and fiber-rich foods
• Consider smaller doses of laxatives when necessary
• Address any underlying emotional or psychological factors

Adults

For most adults, a combination of lifestyle changes and occasional laxative use can manage constipation effectively:

• Focus on diet, hydration, and exercise
• Use laxatives as directed, avoiding overreliance
• Address any medication side effects that may contribute to constipation
• Consider stress management techniques

Older Adults

Seniors may face unique challenges related to constipation:

• Adjust medication regimens that may contribute to the problem
• Ensure adequate mobility and exercise within physical limitations
• Address any underlying health conditions affecting bowel function
• Consider gentler laxative options to avoid dehydration risks

Why is age-specific management important for constipation? Different life stages come with varying physiological needs, medication considerations, and lifestyle factors that can impact digestive health. Tailoring treatment approaches to these specific needs can lead to more effective and safer management of constipation.

Technological Advancements in Digestive Health Management

As medical science progresses, new tools and technologies are emerging to help individuals manage their digestive health more effectively:

• Smart toilets that analyze stool composition and consistency
• Mobile apps for tracking bowel movements and identifying patterns
• Wearable devices that monitor hydration levels
• Personalized gut microbiome testing and analysis

How can these technologies complement traditional constipation treatments? While not replacements for medical advice, these tools can provide valuable insights into individual digestive patterns, helping users and healthcare providers make more informed decisions about diet, lifestyle, and treatment options.

The Future of Constipation Treatment

Ongoing research is exploring new frontiers in digestive health management:

• Targeted probiotics designed for specific digestive issues
• Gene therapy approaches to address inherited bowel disorders
• Bioelectronic medicines that stimulate nerve pathways controlling gut motility
• Advanced imaging techniques for more precise diagnosis of functional bowel disorders

What impact might these advancements have on the use of traditional laxatives? As our understanding of digestive health evolves, we may see a shift towards more personalized and targeted treatments, potentially reducing reliance on broad-spectrum laxatives like glycerin suppositories for some individuals.

Navigating Digestive Health in a Changing World

As global health challenges and lifestyle trends evolve, so too does our approach to managing digestive health:

Impact of Stress and Modern Lifestyles

The fast-paced nature of contemporary life can significantly impact digestive function:

• Increased prevalence of stress-related digestive disorders
• Changes in dietary habits due to convenience foods and busy schedules
• Sedentary lifestyles contributing to reduced gut motility
• Sleep disruptions affecting overall digestive health

How can individuals maintain digestive health in the face of these challenges? Prioritizing stress management, mindful eating, regular physical activity, and adequate sleep can help counteract the negative impacts of modern lifestyles on digestive function.

Environmental Factors and Gut Health

Emerging research suggests that environmental factors may play a role in digestive health:

• Impact of air and water pollution on the gut microbiome
• Effects of climate change on food production and dietary patterns
• Potential links between environmental toxins and inflammatory bowel conditions

What steps can individuals take to protect their gut health in changing environments? While some factors may be beyond individual control, focusing on consuming organic foods when possible, filtering drinking water, and supporting environmentally friendly practices can contribute to both personal and planetary health.

Adult Suppositories Rectal: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Uses

This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes.For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

How to use Adult Suppositories Suppository

This product is for rectal use only. Read and follow all directions on the product package, or use as directed by your doctor. If you have any questions, ask your doctor or pharmacist. If the suppository is too soft to insert, chill in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.

Wash your hands before and after using this product. If the medication is wrapped in foil, remove the foil wrapper. If desired, the suppository may be moistened with lukewarm water. Do not use petroleum jelly or mineral oil. Doing so may cause the product to be less effective.

Lie on your left side with the right knee slightly bent. Using your finger, gently insert the suppository well up into the rectum, pointed end first. After insertion, stay in position for 15 to 20 minutes if possible until you feel a strong urge to have a bowel movement. This product does not need to melt completely to produce an effect. If you are helping a child use this product, have the child lie on their side with the lower leg straightened out and the upper leg bent toward the stomach. Using your finger, gently insert the suppository into the rectum, pointed end first. Hold the buttocks together for a few seconds. Then, have your child stay lying down for 15 to 20 minutes if possible to keep the suppository from coming out.

Do not use this product more than once daily unless otherwise directed by your doctor.

If this product is used too frequently, it may cause loss of normal bowel function and an inability to have a bowel movement without using the product (laxative dependence). If you notice symptoms of overuse, such as diarrhea, abdominal pain, decreased weight, or weakness, contact your doctor promptly.

Consult your doctor promptly if you do not have a bowel movement after using this product or if you think you may have a serious medical problem.

Side Effects

Rectal irritation/burning, abdominal discomfort/cramps, or small amounts of mucus in the stool may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this product, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this product do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: abdominal pain that is severe or doesn’t go away, bloody stools, rectal bleeding.

Diarrhea that doesn’t stop may result in dehydration. Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using glycerin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: rectal bleeding, intestinal blockage (obstruction), other bowel problems (such as ulcerative colitis, hemorrhoids), current stomach/abdominal symptoms (such as nausea/vomiting that doesn’t stop, pain, cramping).

Consult your doctor before using this product if you have had a sudden change in bowel habits lasting more than 2 weeks or if you need to use a laxative for more than 1 week. These could be symptoms of a serious medical problem.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Does Adult Suppositories Suppository interact with other drugs you are taking?

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Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Keep all medical and lab appointments.

Not applicable.

Refer to storage information on the package label. Protect from high heat. Do not store in the bathroom. If you have any questions about storage, ask your pharmacist. Keep all drug products away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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Suppositories are solid medications that enter the body through the rectum, vagina, or urethra. Rectal suppositories are the most common type of suppository.

Doctors recommend the different forms of suppositories for different medical conditions and purposes. People place some in the rectum and others in the vagina. Less commonly, a person will need to use urethral suppositories.

We give step-by-step guidance on how to use suppositories in this article.

We also provide some helpful troubleshooting tips and advice for people who need to use this type of medication.

Share on PinterestPeople use suppositories when they are unable to take drugs orally.

Suppositories are another way to deliver drugs to the body when other routes, such as oral, cannot be used.

A suppository is small and may be round, oval, or cone-shaped. A substance, such as cocoa butter or gelatin, surrounds the medication. The suppository dissolves to release the drug once inside the body.

Suppositories may treat the local area, or the medicine may travel to other parts of the body through the bloodstream.

Why use suppositories?

Suppositories deliver many types of medication, and a person may need to use them if they:

• are having seizures and cannot take medicines by mouth
• are unable to swallow medication for any reason
• are vomiting and cannot keep pills or liquids down
• have a blockage that stops the medication moving through the digestive system

People may also take suppositories if the medication:

• tastes too bad to take by mouth
• would break down too quickly in the gut
• could be destroyed in the gastrointestinal tract

Research also suggests that taking medications through the rectum allows for a relatively constant environment for a drug to be delivered. The rate of absorption may, however, be lower than that of drugs taken by mouth.

There are three types of suppositories:

Rectal suppositories

Rectal suppositories go in the rectum or anus. They are typically an inch long and have a rounded tip.

They treat conditions, such as:

• constipation
• fever
• hemorrhoids
• mental health issues such as anxiety, schizophrenia, or bipolar disorder
• nausea, including motion sickness
• pain

Vaginal suppositories

People may insert vaginal suppositories into the vagina to treat:

• bacterial or fungal infections
• vaginal dryness

Vaginal suppositories are typically oval and come with an applicator.

Urethral suppositories

Men may use a type of urethral suppository to treat erection problems in rare cases.

These suppositories are the size of a grain of rice and deliver a drug called alprostadil.

Anyone using a rectal suppository may want to refer to the following steps for guidance:

1.

Get prepared

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• Try to pass stool to empty the colon, as suppository medication is most effective when the bowel is empty.
• Wash hands thoroughly with soap and warm water or use a hand sanitizer. Dry the hands thoroughly on a clean towel or paper towel.
• Carefully remove the suppository from its wrapper.
• If it is necessary to cut the suppository, use a clean, single-edge razor blade to slice it lengthwise.
• Use a disposable glove, if desired.

2. Get ready to insert the suppository

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• Dip the tip of the suppository in water, or apply a small amount of water-based lubricant, such as K-Y Jelly that is available to buy online. A lubricant helps the suppository more easily slide into the rectum.
• Remove clothing from the lower half of the body.
• Find the correct position. Either stand up with one foot on a chair or lie down on one side with the top leg bent slightly toward the stomach. Caregivers giving the suppository to another person often find it easier if the person is lying down.

3. Insert the suppository

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• Relax the muscles of the buttocks and open the cheeks.
• Gently insert the suppository into the anus, narrow end first.
• Push it in about 1 inch for adults, or half an inch for infants.
• In older children, push the suppository in approximately half to one inch, depending on their size.

4. Relax and clean up

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• Sit or lie still for 10 minutes after inserting the suppository. Staying still allows time for the suppository to dissolve in the body. Parents may need to hold a child’s buttocks closed during this time.
• Dispose of all materials, including the suppository wrapper and any tissue paper.
• Wash the hands thoroughly with soap and warm water.

Try to avoid passing stool for up to 60 minutes after inserting the suppository, unless it is a laxative. Not passing stool gives the medication enough time to enter the bloodstream and start working.

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To place a suppository into the vagina, follow these tips:

1. Get prepared

• Wash hands with soap and warm water, or use a hand sanitizer if these are not available. Dry the hands well on a clean towel or paper towel.
• Unwrap the suppository, and place it in the accompanying applicator.
• Either stand with the knees bent and feet apart or lie down with the knees bent toward the chest.

2. Insert the suppository

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• Place the applicator into the vagina, as far as possible, without causing discomfort.
• Press down on the plunger to push in the suppository.
• Remove the applicator from the vagina, and dispose of it.

3. Relax and clean up

• Lie down for 10 minutes to allow the medicine to enter the body.
• Wash the hands once more with soap and warm water.

Consider using a sanitary towel for a few hours, as some of the suppository may leak out onto the underwear.

To place a suppository into the urethra try the following tips:

1. Get prepared

• Empty the bladder.
• Wash the hands with soap and warm water or use a hand sanitizer. Dry the hands thoroughly on a clean towel or paper towel.
• Remove the applicator cover.

2. Insert the suppository

• Stretch out the penis to open the urethra.
• Place the applicator into the hole at the tip.
• Push the button on the applicator and hold for 5 seconds.
• Gently move the applicator from side to side to ensure the suppository has entered the urethra.
• Remove the applicator.

3. Relax and clean up

• Massage the stretched penis firmly for 10 to 15 seconds to allow the medicine to be absorbed.
• Dispose of the applicator and any other materials.
• Wash the hands once more with soap and warm water.

Suppositories are usually safe to use. Sometimes, some of the medication may leak out. To avoid a mess, people may want to wear a sanitary towel or incontinence pad.

Some people may experience irritation around the area where they inserted the suppository. If this is severe or persists, they should see a doctor.

Occasionally, the body may not absorb the medication delivered by a suppository as well as it does oral medications.

The following tips may help people who need to use suppositories:

• Avoid exercise or vigorous movement for 60 minutes after inserting the medication.
• Do not use petroleum jelly, such as Vaseline, to lubricate the suppository. This stops it from melting. Only use water, or a water-based lubricant.
• Store suppositories in the refrigerator or another cool place, so they do not melt. Always follow the storage directions on the label.
• A soft suppository can be difficult to insert. Gently squeeze it to see if it is firm enough. If not, harden the wrapped suppository by holding it under a flow of cold water. Or, place it in the refrigerator for a few minutes.
• Trim fingernails before inserting suppositories. This prevents cuts and scrapes. Alternatively, wear a latex glove.
• Some people may notice the suppository falls out. This can occur because they have not pushed it far enough into the rectum. Push the medication in about 1 inch.
• Those who struggle to use suppositories should consider asking a partner or caregiver for help.
• As with other medicines, avoid missing doses. Missed doses may reduce the effectiveness of the treatment.

Suppositories are helpful for people who cannot take medications by mouth.

People who have difficulty using suppositories should ask their doctor for advice. They should also talk to their doctor before using suppositories if they:

• have had recent rectal surgery, prostate surgery, or vaginal treatment
• have an irregular heartbeat

Although they may be unpleasant to use, rectal, vaginal, and urethral suppositories can be an effective way of delivering medication.

Suppositories | GxP News

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Suppositories (lat. Suppositorium, i, n), suppositories — dosage forms that are solid at room temperature and melt or disintegrate at body temperature, used for injection into body cavities.

There are rectal suppositories (candles) – Suppositoria rectalia; vaginal – Suppositoria vaginalia and sticks – Bacilli.

Rectal suppositories may be in the form of a cone, a cylinder with a pointed end or other shape with a maximum diameter of 1.5 cm. The mass of one suppository must be between 1 and 4 g. If the mass is not specified, then the suppository is made in a mass of 3 g. The mass of suppositories for children should be from 0.5 to 1.5 g. positories can be spherical (balls) – globuli, ovoid (ovuli) – ovula or in the form of a flat body with a rounded end (pessaries) – pessaria. Their mass should be in the range from 1.5 to 6 g. If the mass is not indicated, then vaginal suppositories are made weighing at least 4 g.

Sticks have the shape of a cylinder with a pointed end and a diameter of not more than 1 cm. The mass of the stick should be from 0.5 to 1 g.

Bases hydrogenated and animal fats, tallow, lanol, hydrogenated fat alloys with wax, hard paraffin and other bases approved for medical use.

Gelatin-glycerol gels, polyethylene oxide alloys with different molecular weights and other substances approved for medical use are used as hydrophilic bases. The gelatin-glycerin base is made from medical gelatin, glycerin and water.

In the manufacture of suppositories, butylated hydroxytoluene, butylated hydroxyanisole, citric acid, emulsifier N1 can be used; emulsifier T-1, emulsifier T-2, tween-80, wool wax alcohols, aerosil and other excipients approved for medical use.

Technology

Medicinal substances, if necessary, are crushed, sieved, mixed with the base directly or after dissolving or grinding with a small amount of water. glycerin, vaseline oil or other suitable solvent. Thermolabile substances are added to the semi-cooled base immediately before the formation of suppositories.

Suppositories are prepared by pouring the molten mass into molds, rolling out or pressing on special equipment. Anhydrous lanolin is used as a binder in the manufacture of suppositories by rolling out.

Quality control

Suppositories must be homogeneous in mass, uniform in shape and have a hardness that ensures ease of use. Homogeneity is determined visually on a longitudinal section by the absence of inclusions. An air rod or a funnel-shaped recess is allowed on the cut.

The average weight is determined by weighing 20 suppositories to the nearest 0.01 g. The deviation in weight should not exceed ±5% and only two suppositories may have a deviation of ±7. 5%.

For suppositories formulated with lipophilic bases, the melting point is determined according to method 2a[2], which should not normally exceed 37°C. If the determination of the melting temperature is difficult, then determine the time of complete deformation according to the application. The time of complete deformation as a rule should be no more than 15 minutes.

For suppositories made from hydrophilic bases, the dissolution time is determined. To do this, one suppository is placed on the bottom of a vessel with a capacity of 100 ml containing 50 ml of water at a temperature of (37±1)°C. The vessels are shaken every 5 minutes so that the liquid and the sample acquire a rotational motion. The suppository should usually dissolve within 1 hour.

Source: Wikipedia

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Manufacture of lipophilic and hydrophilic suppositories.

Suppositories

14 May 2022

In the manufacture of suppositories, active medicinal substances (drugs) are mixed with a base – a substance that determines the biopharmaceutical characteristics of the drug.

Depending on the physical and chemical properties, the bases for the production of candles are divided into 3 groups:

• hydrophobic or lipophilic. This group includes various fat-like substances (for example, cocoa butter), as well as their alloys.
• Hydrophilic or water soluble. These include polyethylene oxide bases (PEO), gelatin and soap-glycerin substances.
• Amphiphilic or hydrophilic-lipophilic. Such bases are alloys of hydrogenated fat with emulsifiers, PEO, paraffins, cocoa butter, as well as alloys of triglycerides of carboxylic acids with monoglycerol esters, etc.

When developing a new drug, the choice of base is carried out taking into account its composition and mechanism of action.

Any substances and alloys used as the basis for pharmaceutical suppositories must:

• within a certain time completely melt or dissolve at a human body temperature – 35-37 degrees Celsius
• remain hard and plastic at room temperature;
• mix with various drugs without entering into chemical interaction with them and without violating their pharmaceutical properties;
• easy to release active ingredients;
• promote the penetration of medicinal components through the mucous membranes;
• do not cause tissue irritation;
• be resistant to physical factors – do not oxidize in the light or under the influence of air, etc. ;
• be resistant to microbiological contamination.

Industrial equipment

The vast majority of factory-made suppositories are produced by casting in special devices. In modern pharmaceutical suppository molding machines, the manufacturing cycle is fully automated. This eliminates the risk of disruption of the technological process due to the “human factor”, increases the efficiency of production and the quality of the finished product.

By setting up the production of suppositories at the factory, pharmacists-technologists adjust industrial installations in accordance with the requirements of the method.

If the formulation of a medicinal product is developed taking into account the characteristics of its components, and the technology is tested and optimized on pilot equipment with appropriate capabilities, the launch of a new production line takes a minimum amount of time, and the finished product fully meets the most stringent standards.

Basic rules for the manufacture of hydrophilic suppositories

For the production of hydrophilic suppositories with a slow release of active substances, alloys of polyethylene oxides are most often used. The advantages of this base include microbiological stability, high strength, slow melting and lack of polymorphism, the disadvantages are incompatibility with a number of chemicals, including silver salts, salicylates, sulfonamides, tannins, etc.

If for the manufacture of water-soluble candles, a mixture of PEO with a predominance of substances with a high molecular weight (from 80 to 98%) and additives of low molecular weight polyethylene oxides (from 2 to 10%), the following sequence of technological operations is established:

• First, the high molecular weight PEO melts at a given temperature (for example, for substances with 1500 mm, the melting point is 55-60°C).
• Then, low molecular weight PEO is poured into the melt with constant stirring until a completely homogeneous mass is obtained, and other additives are also introduced that improve the biopharmaceutical properties of the base (phenol, etc. ).
• Active ingredients are added to the finished base.
• Following this, the suppository mass is again thoroughly mixed and poured into the mold.

When preparing PEO-based suppositories, the following points must be considered:

• Candles of this type can stick to the mucous membrane immediately after insertion into the body cavity. To eliminate this effect, the suppository must be moistened with water before use. This feature of the application should be indicated on the packaging of the medicine.
• Polyethylene oxide bases react with plastic, so only cardboard or glass is used to package such candles.

Basic rules for working with lipophilic bases

Most rectal lipophilic suppositories are made from cocoa butter. The advantages of this hydrophobic base include compatibility with many drugs and the complete absence of an irritating effect on the intestinal mucosa, the disadvantages are a decrease in the melting point to 25-27 ° C, if overheating of the suppository mass over 35-37 ° C was allowed during the manufacturing process.