Hormonal Products & Steroid Medicines | Capsule | CDMO

Overview of hormones & steroid medicines offered by contract service providers (CMO, CDMO) as softgel capsules, hardgel capsules, pills, tablets, etc.

Q1. What are hormonal formulations?

Hormonal formulations are drug products with a mixture of active pharmaceutical ingredients (APIs), specifically hormones along with other inactive components. There are numerous hormonal formulations including hormonal tablets, capsules, liquids and injectables. Hormonal formulations may be used alone, as a main treatment, or with other treatments. It may be used before surgery to shrink the tumour and make it easier to remove or before radiation therapy to shrink the tumour so radiation can be given to a smaller area.

Hormones are chemical substances produced by the body that control and regulate the activity of certain cells or organs. Various hormones are secreted by special glands, such as the thyroid hormone which is produced by the thyroid gland. Hormones are essential for every activity of life, including the processes of digestion, metabolism, growth and reproduction as well as mood control. Many hormones, such as neurotransmitters, are active in more than one physical process.

The various examples of hormones are corticosteroid (steroid) hormones, thyroid hormones, somatostatin analogues, sex (reproductive) hormones such as Androgen, Estrogen, Progestin, Anti-androgens, Anti-estrogens, Aromatase inhibitors, etc.

Steroid Hormones:

Steroids (short for corticosteroids) are synthetic drugs that closely resemble cortisol, a hormone that our bodies produce naturally. Steroids work by decreasing inflammation and reducing the activity of the immune system. They come in pill form (steroid capsules), as inhalers or nasal sprays, and as creams and ointments.
Various CMOs offer outsourcing services for the contract manufacturing of steroid capsules, which are powerful medicines taken to reduce the swelling and inflammation of airways.

Hormonal formulations or hormone pills can be administered as a treatment option for anyone with hormonal imbalances including, but not limited to:

- Levothyroxine. Medications containing levothyroxine, such as Synthroid and Levothroid, can help improve symptoms of hypothyroidism.

- Estrogen Therapy: Treatment for menopause.

- Anti-androgen medications: Women with high androgen levels may choose to take hormone pills as medication that blocks the effect of androgens.

- Testosterone therapy: Testosterone supplements can reduce the symptoms of low testosterone in men.

- Hormonal birth control: Hormonal birth control can help regulate menstrual cycles.

- Hormonal therapy (oncology): A treatment that adds, blocks or removes hormones to slow or stop the growth of cancer cells. Hormonal therapy is also called hormone withdrawal therapy, hormone manipulation or endocrine therapy.

Q2. What are the different components (ingredients) of hormonal capsules?

Hormonal capsules contain hormones as active pharmaceutical ingredients along with other additives in a soft or hard capsule shell. The various components of hormonal capsules are discussed below.

Active Pharmaceutical Ingredients (APIs)

Active pharmaceutical ingredients (APIs) in hormonal capsules are synthetic versions of hormones e.g. estrogen and progesterone (steroidal hormones).

Inactive Components

- Gelatin: (E.g. Bovine, Porcine, Piscine)

Gelatin is an animal protein made by boiling the collagenous material from animal bones, hides, and skin. Depending on its source, gelatin can be divided into two types; Type A, from acidic hydrolysis of animal skin, and Type B, from basic hydrolysis of bovine bones.

- Plasticizer: (E.g. Glycerin & Sorbitol)

Plasticizers are added to polymers used as film forming agents in order to make them pliable and soft, thereby enhancing the flexibility and plasticity of the films.

- Solvent: (E.g. Water)

Water is used as a solvent in capsules.

- Opacifiers: (E.g. Titanium Dioxide)

Opacifiers provide protection against light and photodegradation. They also play a role in concealing the capsules’ inner fill contents.

- Preservatives: (E.g. Antioxidant, Antimicrobial & Chelating Agents)

These agents play a role in the preservation of capsule contents, which increase their shelf life and make capsules safe for consumption.

- Flavorings: (E.g. Essential oils, Sucrose, etc.)

Flavoring agents are used to achieve taste masking in pharmaceutical dosage forms (capsules, hormonal tablets, etc.) in order to make them more suitable and acceptable for ingestion.

- Colorants: (E.g. Dye, Lakes, Mineral Colors, etc.)

Coloring agents can impart various colors to capsule dosage forms. Colorants play an important role in improving patient compliance and can be further selected to complement the disease being treated.

Q3. What are the steps involved in manufacturing of hormonal capsules?

The steps involved in contract manufacturing hormonal capsules are enumerated below.

Hard Gelatin Capsules

Hard gelatin capsules are a modern, solid dosage form for medicinal use, stemming from the increased emphasis on pharmacokinetics found in drug development today. This has considerably expanded the range of possible formulations utilising hard gelatin capsules as a simple solid oral dosage form for drug delivery.

Formulation & Manufacturing of Empty Hard Gelatin Capsules:

Step 1: Preparation of gelatin solution or dipping solution for the two-piece capsule machines.

Step 2: Dip coating solution onto metal pins to simultaneously form the caps & the bodies.

Step 3: Rotation of dip coated pins to distribute gelatin over the pins uniformly.

Step 4: Drying the gelatin coated pins to remove water and solidify the hard gelatin capsule shells.

Step 5: Stripping & trimming.

Step 6: Joining the trimmed capsule shells, after which the capsules are ejected from the two-piece capsule machine.

Step 7: Polishing & printing.

Filled Hard Gelatin Capsules:

Step 8: Developing & preparing the inner fill formulation containing synthetic hormones as active pharmaceutical ingredients (or cytotoxic and high potency hormones) along with other formulations additives.

Step 9: Filing hard capsule shells via manual, semi automatic or automatic filling devices.

Step 10: Sealing the dry filled capsules.

Step 11: Cleaning & polishing the dry filled capsules.

Softgels

Soft-gelatin capsule technology enables the production of unit dose solid dosage forms referred to as soft gelatin capsules. Various contract service providers (CDMO & CMO) enable outsourcing the use of soft-gelatin capsule technologies for various non-sterile dosage forms and solid oral dosage form applications to bring superior compounds to market faster. They may have capabilities for contract manufacturing of steroid capsules and contract manufacturing for hormonal capsules.

Formulation & Manufacturing of Soft Gelatin Capsule:

Step 1: Raw Material - Storage & Selection

Step 2: Weighing Soft Gelatin Capsule Ingredients - Inner & Outer Fills

Step 3: Preparation - Inner Fill Material & Soft Shells

Step 4: Soft Gelatin Encapsulation

Process of Encapsulation:

Step 1: The prepared inner fill and outer fill materials containing hormonal preparations or cytotoxic and high potency hormone drugs are transported to encapsulation bays.

Step 2: Each encapsulation capsule manufacturing machine is segregated into individual bays.

Step 3: Molten gel is pumped into the machines.

Step 4: Two thin ribbons of gel are formed, on either side of the soft gel manufacturing encapsulation machines.

Step 5: The ribbons are passed over a series of rollers and dies that help in determining the size of the capsules.

Step 6: Softgel Dosage Form Inspection

Step 7: Soft Shell Capsule Packaging

Step 8: Finished Product Storage & Distribution

- During the formulation and manufacturing of solid dosage forms such as capsules, medicinal concoctions are filled into the body of the empty capsules before the cap is pushed into place or inner fill materials are selected according to desired therapeutic effects in soft gelatin capsules. Contract manufacturing of hormonal capsules uses hormonal active pharmaceutical ingredients (APIs) as inner fill materials in both soft gel and hard gel dosage forms.

Q4. Who are the leading contract manufacturers for steroid capsules / hormonal capsules?

There are various contract service providers including CDMOs (contract development and manufacturing organizations) and CMOs offering specialized services such as drug product development and manufacturing of cytotoxic and high potency hormone drugs products (hormonal products), including hormone pills and steroid medicines. They have capabilities of outsourcing the contract manufacturing of steroid capsules and contract manufacturing for hormonal capsules.

Madras Pharmaceuticals

Madras Pharmaceuticals is a pharmaceutical contract manufacturer which has seven state-of-the-art world class facilities (CMO facilities) equipped with ultramodern plants and machineries for manufacturing a wide range of pharmaceutical dosage forms, including; hormonal tablets, hard & soft gelatin capsules, dry & liquid syrups, dry & liquid injectables, nutraceuticals, dermatological & other hormonal products.

Steril-Gene, a division of Madras Pharma, provides contract manufacturing solutions to the pharmaceutical industry. Their 20 acre factory, located in Pondicherry (India), consists of 4 major state-of-the-art manufacturing facilities for hormones, potents, injections, and solid oral dosage forms. They offer contract manufacturing for hormonal capsules. Furthermore, Steril-Gene's hormone block has a capacity of 300 million soft gelatin capsules per annum.

Cyndea Pharma S.L

Cyndea Pharma is a pharmaceutical contract development & manufacturing organization offering the development and manufacture of steroid based generic drugs. Their generic steroid based drugs correspond to the therapeutic class of sex hormones and regulators of gonadal function: Mainly including the progestins, estrogens and androgens group. Cyndea Pharma is a leading contract manufacturer with proper facilities for handling hormonal formulations or hormonal products as non-sterile dosage forms along with steroid medicines; They offer contract manufacturing of steroid capsules.

Cyndea Pharma offers specialized services including drug product development and manufacturing of steroid medicines as oncology treatment for hormone-dependent tumours (e.g. breast cancer, endometrial cancer, uterine cancer or prostate cancer). Cyndea Pharma makes use of specific technology for the contract manufacturing of steroid capsules (soft gelatin capsules).

Corden Pharma

Corden Pharma is a pharmaceutical contract development and manufacturing organization offering drug product development & manufacturing for oral formulations such as tablets and capsules. CordenPharma meets the pharmaceutical industry’s recent demand for more complex and potent compounds (e.g. hormones, hormone blockers, oncology), and cytotoxic formulation products.

CordenPharma’s expert development teams offer specialized services for pharmaceutical dosage forms (sterile and non-sterile dosage forms including oral formulations) with highly potent substances such as hormones, cytostatics, and beta-lactams in appropriate facilities. They also offer contract manufacturing for hormonal capsules.

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